POLYSTAN WIRE REINFORCED CATHETERS AND CANNULAE
FDA 510(k) clearance K872182 · decided 1987-10-30
Clearance details
- K-number
- K872182
- Device name
- POLYSTAN WIRE REINFORCED CATHETERS AND CANNULAE
- Applicant
- Polystan C/O Vitalcor, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-06-08
- Decision date
- 1987-10-30
- Days to decision
- 144 days
- Clearance type
- Traditional
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Westmont, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.