8810 PUMP-PUMP SINGLE NEEDLE DEVICE
FDA 510(k) clearance K873279 · decided 1987-10-23
Clearance details
- K-number
- K873279
- Device name
- 8810 PUMP-PUMP SINGLE NEEDLE DEVICE
- Applicant
- Cd Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-08-17
- Decision date
- 1987-10-23
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- FIF
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Portland, OR, 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 |
|---|---|---|
| COBE SINGLE-NEEDLE CONTROLLER #18-756 (K820173) | Cobe Laboratories, Inc. | 1982-03-23 |
| BELLCO SINGLE NEEDLE DOUBLE HEAD PUMP (K802230) | Cardio Med Supplies, Inc. | 1980-12-22 |
| MEDCOMP FEMORAL VEIN CATHETER (K801967) | Medical Components, Inc. | 1980-09-26 |
| MODEL DM 353 & DM-353-L SINGLE NEEDLE (K792174) | Extracorporeal Medical Specialities, Inc. | 1979-11-16 |
| GW 35 GUIDE WIRE (K772147) | Sorensen Research | 1977-11-28 |
Recalls involving this device
No recalls on record reference this clearance.