Identity
- Trade Name
- PerClot® Polysaccharide Hemostatic System FDA PMA
- Generic Name
- Agent, absorbable hemostatic, non-collagen based FDA PMA
Identifiers
- PMA Number
- P210036 FDA PMA
- FDA Product Code
- LMG FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Legislation / Framework
- 21 CFR Part 878.4490 FDA PMA
- Regulation Number
- 878.4490 FDA PMA
- Advisory Committee
- General, Plastic Surgery FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The PerClot Absorbable Hemostatic Powder is a non-collagen-based absorbable hemostatic agent designed to assist in controlling bleeding during surgical procedures. It is intended for use in general and plastic surgery, particularly when conventional methods such as pressure, ligature, or suturing are ineffective or impractical for managing suture line bleeding or capillary, venous, and arteriolar bleeding—excluding neurological and ophthalmic applications.
This single-use, sterile powder is supplied as an adjunctive hemostatic device and is regulated under FDA Premarket Approval (PMA P210036). It is classified as a Class III medical device under regulation number 878.4490 and is intended for use in controlled surgical environments. The product is packaged and stored according to manufacturer guidelines to maintain sterility and efficacy.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P210036 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Baxter Healthcare Corporation
Sources (1)
- FDA PMA P210036 23 fields · synced Oct 6, 2026