MODIFICATION'S TO TORAY'S B-2 SERIES
FDA 510(k) clearance K863297 · decided 1986-09-25
Clearance details
- K-number
- K863297
- Device name
- MODIFICATION'S TO TORAY'S B-2 SERIES
- Applicant
- National Medical Care, Medical Products Div., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-08-25
- Decision date
- 1986-09-25
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- FJT
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Rockleigh, NJ, 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 |
|---|---|---|
| CATHETER, FEMORAL VEIN, SF 6 (K772148) | Sorensen Research | 1977-11-29 |
| CATHETER, VEIN, FEMORAL, SF 10 (K772146) | Sorensen Research | 1977-11-29 |
| DNC 151 VINCA-FLO (K770047) | Sorensen Research | 1977-01-14 |
| TRIEX-1 HOLLOW FIBER DIALYZER (K760781) | Extracorporeal Medical Specialities, Inc. | 1976-12-06 |
Recalls involving this device
No recalls on record reference this clearance.