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Swan-Ganz 131F7P

by Becton, Dickinson and Company United States GUDID

Product code DYG

Regulatory status

as of 25 Oct 2026

Recall ongoing. 2 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00885403522270 UDI-DIDate30 May 2026ListedStatusIn distribution

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — GUDID listing Listed

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-2203-2026 FDA Class II initiated 8 Apr 2026
    • Ongoing Z-2202-2026 FDA Class II initiated 8 Apr 2026 via K231248, on the same 510(k)

    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.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

GUDID · synced 22 Oct 2026

Trade Name
Swan-Ganz
Generic Name
Pulmonary artery balloon catheter, electrical
Model / Reference
131F7P
Primary DI / UDI-DI
00885403522270
510(k) Number
FDA Product Code
DYG, DQO
GMDN Term
Pulmonary artery balloon catheter, electrical
Device Class
Class II
Regulation Number
870.1240, 870.1200
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Unsafe
Size
Length — 110 Centimeter
Outer Diameter — 2.3 Millimeter

Related devices

Cleared under the same submission (K231248)

Show all (12)

Other devices from Becton, Dickinson and Company

See all devices from Becton, Dickinson and Company →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • FDA UDI cdded75e-10d8-4da0-b172-5fed8f3a6cc1 36 fields · synced 22 Oct 2026