510(k) Report

FDA applicant

Baxter Edwards

Irvine, CA11 decisions1993–20006 recalls

FDA records 11 decisions for Baxter Edwards (Irvine, CA) from 1993 to 2000: 11 510(k) clearances. Most are in product codes LYK (Angioscope) and DYG (Catheter, Flow Directed). Its devices cite 3 predicates, 0 of them its own earlier devices. 6 recalls are linked to its devices, 1 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Baxter Edwards’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Baxter Edwards since 2007.

Recalls per year

1in 2016

2009: 12011: 22015: 12016: 1, 1 Class I
2007high 2 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Baxter Edwards by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LYKAngioscope2decisions
  • DYGCatheter, Flow Directed1decision
  • HCGDevice, Neurovascular Embolization1decision
  • DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter1decision
  • DYBIntroducer, Catheter1decision
  • MGZValvulotome1decision

Also: DTJ (1), KRH (1), MCW (1), FOZ (1).

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 13 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K9526384.5F Imagecath Coronary Angioscope, Model COV45 [Subsequently Referred to as the Modified Angioscope[Baxter Edwards · 19953cite it
  • K981909Baxter Hemostasis Valve IntroducersBaxter Edwards · 19983cite it
  • K944858Baxter Eptfe Externally Supported Vascular GraftsBaxter Edwards · 19952cite it
  • K993816Baxter Percutaneous Mechanical Thrombectomy (PMT) Device, Models PMT0606FD and PMT1206FDBaxter Edwards · 20002cite it
  • K955839Multi-Med Multi-Lumen Central Venous CatheterBaxter Edwards · 19962cite it
  • K940795Swan-Ganz CC0/SVO2 Thermodilution CatheterBaxter Edwards · 19941cites it

What has FDA decided for it lately?

  • K993816Baxter Percutaneous Mechanical Thrombectomy (PMT) Device, Models PMT0606FD and PMT1206FDBaxter Edwards · 2000
  • K981909Baxter Hemostasis Valve IntroducersBaxter Edwards · 19983 recalls
  • K980487Carpenter-Edwards Classic Ring with Duraflo Treatment Models 4425 (Mitral) and 4525 (Tricuspid)…Baxter Edwards · 1998
  • K965137Fogarty Valvulotome Model 700091Baxter Edwards · 1997
  • K964021Intramed Side Branch Occlusion (Sbo) System (700095 and 700099)Baxter Edwards · 1997
  • K955839Multi-Med Multi-Lumen Central Venous CatheterBaxter Edwards · 19961 Class I recall
  • K9526384.5F Imagecath Coronary Angioscope, Model COV45 [Subsequently Referred to as the Modified Angioscope[Baxter Edwards · 1995
  • K944214Baxter Handle Model 1150Baxter Edwards · 1995

All 11 as Baxter Edwards →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K955839Multi-Med Single Lumen Catheters sold in Centurion convenience kits. The Multi-Med…Oct 21, 2016Class I
  • K940795Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed…May 5, 2015Class II
  • K023880Steerable Coronary Sinus Catheter, Model SCS01, 9 Fr x 20.4", Sterile R, Edwards…Jun 15, 2011
  • K964248Endopledge Sinus Catheter Kit, REF: EP, 9 Fr x 18.9", Sterile EO, Sterile R, Edwards…Jun 15, 2011
  • K981909Edwards LifeSciences, Percutaneous Sheath Introducer Set, Rx only, For single use only.…May 11, 2009
  • K902628EDWARDS VIGILANCE MONITORS (FORMERLY BAXTER VIGILANCE MONITORS) with software release…Jun 21, 2006

Other applicant names beginning “Baxter”

FDA records each applicant name separately; these may or may not be the same firm.

Baxter Healthcare Corp 574Baxter Diagnostics, Inc. 72Baxter Bentley Laboratories, Inc. 3Baxter Healthcare Corportation 3Baxter Healthcare Corporation - Renal Division 2Baxter/ Synovis Micro Companies Alliance, Inc. 2Baxter Healthcare Corp/ Excel Medical 1Baxter Centre For Medical Research 1Baxter Healthcare Corproration 1Baxter Corp. 1Baxter Interwoven Offsite 1Baxter Healthcare Corp., Bioscience 1