PILLING BRUSH VALVULOTOME
FDA 510(k) clearance K904507 · decided 1991-03-01
Clearance details
- K-number
- K904507
- Device name
- PILLING BRUSH VALVULOTOME
- Applicant
- Pilling Co.
- Decision
- Substantially Equivalent
- Date received
- 1990-10-02
- Decision date
- 1991-03-01
- Days to decision
- 150 days
- Clearance type
- Traditional
- Product code
- DWQ
- Device class
- 2
- Regulation number
- 870.4885
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Fort Washington, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PhasTIPP (K212894) | LeMaitre Vascular, Inc. | 2022-03-31 |
| SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023 (K041453) | Smith & Nephew, Inc. | 2004-07-22 |
| TRIVEX SYSTEM (K032387) | Smith & Nephew, Inc. | 2003-10-29 |
| URESIL VALVE CUTTER (K905528) | Uresil Corp. | 1991-04-18 |
| INSITUCAT VALVE STRIPPER (K885046) | Aesculap Instruments Corp. | 1990-02-28 |
| HALL VEIN STRIPPER (K872157) | Solco Basle, Inc. | 1987-07-07 |
| VEIN-TRAP TM (K811910) | Atrium Medical Corp. | 1981-07-20 |
Recalls involving this device
No recalls on record reference this clearance.