SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS.
FDA 510(k) clearance K885235 · decided 1989-01-25
Clearance details
- K-number
- K885235
- Device name
- SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS.
- Applicant
- Spectramed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-12-20
- Decision date
- 1989-01-25
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- DSK
- Device class
- 2
- Regulation number
- 870.1110
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Oxnard, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Safedraw Venous Close Loop System, Blood Sampling Set, packaged in a tyvek bag, Model/Part recall (Z-1946-2012) | Argon Medical Devices, Inc | 2012-07-06 |