HAEMONETICS CELL SAVER MINI SAVER AUTO. BLOOD SYS.
FDA 510(k) clearance K872895 · decided 1988-01-11
Clearance details
- K-number
- K872895
- Device name
- HAEMONETICS CELL SAVER MINI SAVER AUTO. BLOOD SYS.
- Applicant
- Haemonetics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1987-07-23
- Decision date
- 1988-01-11
- Days to decision
- 172 days
- Clearance type
- Traditional
- Product code
- CAL
- Device class
- 1
- Regulation number
- 868.5530
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Braintree, MA, 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 |
|---|---|---|
| FI-10P (K951195) | Pentax Precision Instrument Corp. | 1995-04-06 |
| FI-10M (K951194) | Pentax Precision Instrument Corp. | 1995-04-06 |
| REICHERT FLEXIBLE LARYNGOSCOPE, MODEL LS-11 (K852994) | Reichert-Jung, Inc. | 1985-07-29 |
| OLYMPUS LF-1 INTUBATION SCOPE (K850978) | Olympus Corp. | 1985-05-23 |
| AO FLEXIBLE LARYNGOSCOPE, #LS-7 (K802331) | American Optical Corp. | 1980-10-10 |
| AO STYLET LARYNGOSCOPE MODEL SLS (K801364) | American Optical Corp. | 1980-06-17 |
| AO STYLET LARYNGOSCOPE, MODEL SLS-1 (K791634) | American Optical Corp. | 1979-09-17 |
Recalls involving this device
No recalls on record reference this clearance.