FlexCath Contour™ Steerable Sheath

510(k) premarket notification. Decision: Substantially Equivalent, 31 October 2023. Product code DRA.

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	K232321	k_number
Device name	FlexCath Contour™ Steerable Sheath	device_name
Applicant	Medtronic, Inc.	applicant
Decision date	2023-10-31	decision_date
Decision	Substantially Equivalent	decision
Product code	DRA	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, K232321, retrieved 2026-10-16 03:15 Eastern. Public domain (CC0).

Product code

The FDA classification record for the code on this record.

DRA

Catheter, Steerable

Device class 2 · Regulation 870.1280 · Review panel CV

All records with this codeClassification record on FDA

ArrHub vocabulary

Electrophysiology

DRA 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 20 September 2026.

ArrHub

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

Resolved to

Medtronic

The register name above is resolved to its organisation under ArrHub’s alias table. Method: rule:normalize. Source: fda_applicant. Verified 20 September 2026.

Not yet in ArrHub’s weekly snapshot.

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/510k.json?search=k_number:K232321&limit=1

{
  "id": "43c19913-a4f8-425a-a5e5-f959b5368bc9",
  "k_number": "K232321",
  "device_name": "FlexCath Contour Steerable Sheath",
  "applicant": "Medtronic, Inc.",
  "decision_date": "2023-10-31",
  "decision": "Substantially Equivalent",
  "product_code": "DRA",
  "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=K232321",
  "verified_at": "2026-10-16T07:15:13.707+00:00",
  "created_at": "2026-10-16T07:15:18.677639+00:00",
  "updated_at": "2026-10-16T07:15:03.832+00:00",
  "collected_at": "2026-10-16T07:15:03.832+00:00",
  "last_checked_at": "2026-10-16T07:15:13.707+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.

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