510(k) Report

FDA applicant

Bio-Vascular, Inc.

St. Paul, MN26 decisions1986–200012 recalls

FDA records 26 decisions for Bio-Vascular, Inc. (St. Paul, MN) from 1986 to 2000: 26 510(k) clearances. Most are in product codes FTM (Mesh, Surgical) and DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe…). Its devices cite 28 predicates, 21 of them its own earlier devices. 12 recalls are linked to its devices.

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 Bio-Vascular, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bio-Vascular, Inc. since 2007.

Recalls per year

4in 2024

2013: 22016: 12022: 12023: 32024: 4
2007high 4 (2024) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Bio-Vascular, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FTMMesh, Surgical7decisions
  • DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene4decisions
  • GXQDura Substitute3decisions
  • DXCClamp, Vascular3decisions
  • DWPDilator, Vessel, Surgical2decisions
  • LLZSystem, Image Processing, Radiological1decision

Also: PAJ (1), DWS (1), HQX (1), DTR (1), FTL (1), MTZ (1).

Whose devices does it build on?

Its devices cite 28 predicates; 21 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 85 times; 21 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.

  • K983162Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve, Peri-Strips-Strips…Bio-Vascular, Inc. · 199813cite it
  • K983602CV Peri-Guard and Vascu-GuardBio-Vascular, Inc. · 199810cite it
  • K923657Supple Peri-GuardBio-Vascular, Inc. · 19929cite it
  • K921895Tissue Patch, Tissue GraftBio-Vascular, Inc. · 19927cite it
  • K942010Vascu-GuardBio-Vascular, Inc. · 19946cite it
  • K950956Dura-Guard Dural Repair Patch, Dura-Guard Dura SubstituteBio-Vascular, Inc. · 19956cite it

What has FDA decided for it lately?

  • K002233Bvi SlingBio-Vascular, Inc. · 20001 recall
  • K992537Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated and Naoh-TreatedBio-Vascular, Inc. · 2000
  • K983602CV Peri-Guard and Vascu-GuardBio-Vascular, Inc. · 19983 recalls
  • K983581Ocu-Guard and Ocu-Guard SuppleBio-Vascular, Inc. · 1998
  • K983162Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve, Peri-Strips-Strips…Bio-Vascular, Inc. · 19982 recalls
  • K981624Flo-ThruBio-Vascular, Inc. · 19983 recalls
  • K982282Dura-Guard - Dural Repair PatchBio-Vascular, Inc. · 19981 recall
  • K971726CV Peri-Guard - Cardiovascular PatchBio-Vascular, Inc. · 1998

All 26 as Bio-Vascular, Inc. →

What has been recalled?

12 recalls linked to its devices; the latest:

  • K983162Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO, b)…Feb 28, 2024Class II
  • K983162Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b) PC0608NBIO, c)…Feb 28, 2024Class II
  • K981624Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers…Feb 22, 2024Class II
  • K942812Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers…Feb 22, 2024Class II
  • K883696Baxter Flo-Rester, Disposable internal vessel occluder, distributed in the following…Dec 6, 2023Class II
  • K981624Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100, 1.00 GLOBAL…Dec 6, 2023Class II