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Swan-Ganz D97130F5

by Becton, Dickinson and Company

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00885403521624 UDI-DI Date4 Sep 2026ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2204-2026 FDA Class II initiated 8 Apr 2026

    Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Swan-Ganz
Generic Name
Temporary cardiac pacing balloon catheter
Model / Ref / Catalog
D97130F5
Primary DI / UDI-DI
00885403521624
510(k) Number
FDA Product Code
DYG, LDF
GMDN Term
Temporary cardiac pacing balloon catheter
Device Class
Class II
Regulation Number
870.1240, 870.3680
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe
Size
Outer Diameter — 1.67 Millimeter
Length — 90 Centimeter

Related devices

Cleared under the same submission (K233983)

Other devices from Becton, Dickinson and Company

See all devices from Becton, Dickinson and Company →

Properties

  • Sterile
  • Single Use
  • Contains Latex
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (6)

  • Implantable: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No