INTERPLEURAL ANESTHESIA KIT W/POLYURETHANE CATH.
FDA 510(k) clearance K891281 · decided 1989-07-14
Clearance details
- K-number
- K891281
- Device name
- INTERPLEURAL ANESTHESIA KIT W/POLYURETHANE CATH.
- Applicant
- Arrow Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-03-09
- Decision date
- 1989-07-14
- Days to decision
- 127 days
- Clearance type
- Traditional
- Product code
- CAZ
- Device class
- 2
- Regulation number
- 868.5140
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Reading, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.