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Swan-Ganz Ccombo V 777F8

by Becton, Dickinson and Company GUDID

Listed (no authorization) FDA GUDID database listing only

Regulatory status

as of 26 Oct 2026

Recall ongoing on a related submission. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00885403522348 UDI-DIDate30 May 2026ListedStatusIn distribution

Coverage

1 jurisdiction

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

United States — GUDID listing Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2202-2026 FDA Class II initiated 8 Apr 2026 via K233824, 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

Trade Name
Swan-Ganz Ccombo V
Generic Name
Pulmonary artery balloon catheter, electrical
Model / Reference
777F8
Primary DI / UDI-DI
00885403522348
510(k) Number
FDA Product Code
KRA, DYG
GMDN Term
Pulmonary artery balloon catheter, electrical
Device Class
Class II
Regulation Number
870.1210, 870.1240
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Unsafe
Size
Length — 110 Centimeter
Outer Diameter — 2.7 Millimeter

Related devices

Cleared under the same submission (K233824)

Other devices from Becton, Dickinson and Company

See all devices from Becton, Dickinson and Company →

Properties

Show 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