Introducer, Catheter

FDA product classification. Device class 2. Review panel CV.

Classification

Each row is one field of the openFDA record. The grey name is the field’s name in openFDA’s documentation.

Field	Value	Field name
Product code	DYB	product_code
Device name	Introducer, Catheter	device_name
Device class	2	device_class
Review panel	CV	review_panel
Regulation number	870.1340	regulation_number
Medical specialty	Cardiovascular	medical_specialty

Source: FDA openFDA, device/classification, product code DYB, as held in ArrHub’s controlled vocabulary with its citation. Public domain (CC0).

PMA records with this code

Every verified record ArrHub holds under the code, newest first.

None in the verified view.

510(k) clearances with this code

Every verified record ArrHub holds under the code, newest first.

Decision	Applicant	Device	Record
2026-04-10	Protaryx Medical, Inc.	Protaryx Transseptal Puncture Device (PTX2-001)	K260839 FDA
2023-12-17	Acutus Medical, Inc.	FlexCath Cross Transseptal Solution	K233691 FDA
2023-09-27	Inari Medical, Inc.	Talon Transseptal Sheath	K231108 FDA
2022-05-09	Baylis Medical Company, Inc.	VersaCross Connect Transseptal Dilator	K220414 FDA
2022-03-24	Dib Ultranav Medical, LLC	Dib UltraNav Transseptal Catheter System	K213492 FDA
2022-03-23	Shanghai Microport EP Medtech Co., Ltd.	PathBuilder Transseptal Guiding Introducer	K212626 FDA
2022-02-08	Acutus Medical, Inc.	AcQCross Qx Integrated Transseptal Dilator/Needle	K220047 FDA
2021-07-06	East End Medical I, LLC	SafeCross Transseptal Puncture and Introducer (TSP/I) System	K203459 FDA
2021-04-06	Acutus Medical, Inc.	AcQCross Qx Integrated Transseptal Dilator/Needle	K210685 FDA
2019-05-20	Baylis Medical Company, Inc.	VersaCross Transseptal Sheath	K183655 FDA
2019-04-17	Baylis Medical Company, Inc.	VersaCross Steerable Sheath, VersaCross Transseptal Dilator	K190688 FDA

ArrHub

What ArrHub adds to the record. Everything above this line is the agency’s; everything here is ArrHub’s, dated and attributed.

ArrHub vocabulary

Electrophysiology

DYB is one of the 61 product codes in ArrHub’s electrophysiology vocabulary, each held with its FDA classification record as its citation. Vocabulary entry verified 16 October 2026.

Raw record

The stored record exactly as ArrHub holds it, for anyone who wants to check the page against it.

Show the raw record (JSON)device/classification.json?search=product_code:DYB

{
  "id": "fda_product_code:DYB",
  "vocabulary": "fda_product_code",
  "term": "DYB",
  "definition": "Introducer, Catheter",
  "attrs": {
    "name_filter": "TRANSSEPTAL",
    "device_class": "2",
    "review_panel": "CV",
    "medical_specialty": "Cardiovascular",
    "regulation_number": "870.1340"
  },
  "jurisdiction": "US",
  "authority": "FDA",
  "ep_relevant": true,
  "source_url": "https://api.fda.gov/device/classification.json?search=product_code:DYB",
  "verified_by": "Bruno Deslauriers",
  "verified_at": "2026-10-16T08:08:36.55243+00:00",
  "notes": "Fetched from https://open.fda.gov/apis/device/classification/ Added 2026-10-16 by the editor's OD1 (DRA plus DYB name filter, transseptal as a sub-segment). Held for the transseptal sub-segment only: the ingestion stores a DYB record when its device_name carries TRANSSEPTAL (fda-ingestion.ts NAME_FILTERS); the rest of the code is not stored.",
  "created_at": "2026-10-16T08:08:36.55243+00:00",
  "updated_at": "2026-10-16T08:08:36.55243+00:00"
}

The readable page is rendered from the record held in ArrHub’s verified view; the agency record at api.fda.gov governs where they differ.

Links open the agency’s own records. Unlabelled links open web pages. Links marked (JSON) open an agency’s data record, which a browser shows as plain text.

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