MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE
FDA 510(k) clearance K880740 · decided 1988-03-22
Clearance details
- K-number
- K880740
- Device name
- MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE
- Applicant
- Spectramed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-02-24
- Decision date
- 1988-03-22
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- DQF
- Device class
- 2
- Regulation number
- 870.1670
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Oxnard, CA, 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 |
|---|---|---|
| VERSA-VIAL (K920177) | Bioteque America, Inc. | 1992-07-13 |
| ALCON FLUID INJECTOR (K882723) | Alcon Laboratories | 1988-11-08 |
Recalls involving this device
No recalls on record reference this clearance.