SafeCross Transseptal Puncture and Introducer (TSP/I) System

510(k) premarket notification. Decision: Substantially Equivalent, 6 July 2021. Product code DYB.

Clearance

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
510(k) number	K203459	k_number
Device name	SafeCross Transseptal Puncture and Introducer (TSP/I) System	device_name
Applicant	East End Medical I, LLC	applicant
Decision date	2021-07-06	decision_date
Decision	Substantially Equivalent	decision
Product code	DYB	product_code
Device class	null	device_class
Review panel	Cardiovascular	review_panel
Clearance type	Traditional	clearance_type
Statement or summary	Summary	summary_type
Regulation number	null	regulation_number
Predicate devices	null	predicate_devices

Source: FDA openFDA, device/510k, K203459, retrieved 2026-10-16 04:14 Eastern. Public domain (CC0).

Product code

The FDA classification record for the code on this record.

DYB

Introducer, Catheter

Device class 2 · Regulation 870.1340 · Review panel CV

All records with this codeClassification record on FDA

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.

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Resolution

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Raw record

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Show the raw record (JSON)device/510k.json?search=k_number:K203459&limit=1

{
  "id": "20cc595c-4dcf-4dd2-b6fb-763101732fee",
  "k_number": "K203459",
  "device_name": "SafeCross Transseptal Puncture and Introducer (TSP/I) System",
  "applicant": "East End Medical I, LLC",
  "decision_date": "2021-07-06",
  "decision": "Substantially Equivalent",
  "product_code": "DYB",
  "device_class": null,
  "review_panel": "Cardiovascular",
  "clearance_type": "Traditional",
  "summary_type": "Summary",
  "regulation_number": null,
  "predicate_devices": null,
  "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203459",
  "verified_at": "2026-10-16T09:43:55.561+00:00",
  "created_at": "2026-10-16T08:14:39.760778+00:00",
  "updated_at": "2026-10-16T08:14:24.56+00:00",
  "collected_at": "2026-10-16T08:14:24.56+00:00",
  "last_checked_at": "2026-10-16T09:43:55.561+00:00"
}

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