MODIFIED RT. ARTRIAL AND 13.5X11.5F CATH. TRAY
FDA 510(k) clearance K885188 · decided 1989-02-06
Clearance details
- K-number
- K885188
- Device name
- MODIFIED RT. ARTRIAL AND 13.5X11.5F CATH. TRAY
- Applicant
- Quinton, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-12-07
- Decision date
- 1989-02-06
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- DWF
- Device class
- 2
- Regulation number
- 870.4210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Seattle, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.