PerClot® Polysaccharide Hemostatic System
FDA premarket approval P210036 · decided 2023-05-19
Approval details
- PMA number
- P210036
- Trade name
- PerClot® Polysaccharide Hemostatic System
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- Baxter Healthcare Corporation
- Date received
- 2021-10-25
- Decision date
- 2023-05-19
- Days to decision
- 571 days
- Decision code
- APPR
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Round Lake, IL
- Statement
- Approval for the PerClot® Absorbable Hemostatic Powder. The device is indicated in surgical procedures (except neurological and ophthalmic) as an adjunctive hemostatic device to assist when control of suture line bleeding or capillary, venous and arteriolar bleeding by pressure, ligature, and other conventional procedures is ineffective or impractical.
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510(k) clearances by this applicant
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|---|---|---|
| Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) (K251745) | Baxter Healthcare Corporation | 2025-12-16 |
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| Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) (K251636) | Baxter Healthcare Corporation | 2025-07-28 |
| Solution Administration Sets (K243529) | Baxter Healthcare Corporation | 2025-03-14 |
| Intravascular Extension Sets and Accessories (K242339) | Baxter Healthcare Corporation | 2025-02-28 |
| Novum IQ Syringe Pump (40800BAXUS) (K242390) | Baxter Healthcare Corporation | 2024-09-05 |
| Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS (K241564) | Baxter Healthcare Corporation | 2024-08-02 |
| Novum IQ Large Volume Pump (K211122) | Baxter Healthcare Corporation | 2024-03-29 |