Bioflow(Tm)

No FDA recalls found in the data synced 6 Oct 2026.

Generic Name

Graft, vascular, hemodialysis access, synthetic/biological composite

PMA Number

P800064 ↗

FDA Product Code

MCI

Device Class

Class III

Advisory Committee

Obstetrics/Gynecology

FDA Decision

APPR Approved

• Periguard Pericardial Patch

  Class II

  FDA 510(k) K821532 Active Cleared 19 Aug 1982

• Suture Strip

  Class I

  FDA 510(k) K842621 Active Cleared 25 Oct 1984

• Peri-Guard Pericardial Patch

  Class II

  FDA 510(k) K842066 Active Cleared 30 Dec 1985

• What is the Bioflow™ vascular graft specifically designed for in clinical practice?

  The Bioflow™ graft is designed to create vascular pathways for hemodialysis access, enabling long-term dialysis procedures in patients undergoing renal replacement therapy. It serves as a synthetic/biological composite conduit to facilitate reliable blood flow for repeated dialysis sessions.

• Is the Bioflow™ graft intended for reuse or is it meant to be used only once?

  The Bioflow™ graft is explicitly intended for single-use only, as stated in its specifications. This ensures sterility and safety for each patient procedure, aligning with standard sterile medical device protocols.

• How should the Bioflow™ graft be stored to maintain its integrity before use?

  The Bioflow™ graft must be stored and handled according to sterile medical device protocols to preserve its sterility. Since it is supplied sterile and single-use, proper storage conditions are critical to prevent contamination before clinical application.

• What regulatory pathway does the Bioflow™ graft follow, and what is its FDA classification?

  The Bioflow™ graft is classified as a Class III medical device and follows the FDA Premarket Approval (PMA) pathway. It holds PMA number P800064 and is categorized under product code MCI for vascular grafts, reflecting its high-risk classification for patient safety.