INTERPLEURAL ANESTHESIA CATHETER
FDA 510(k) clearance K971851 · decided 1998-01-22
Clearance details
- K-number
- K971851
- Device name
- INTERPLEURAL ANESTHESIA CATHETER
- Applicant
- Axiom Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-05-20
- Decision date
- 1998-01-22
- Days to decision
- 247 days
- Clearance type
- Traditional
- Product code
- BSO
- Device class
- 2
- Regulation number
- 868.5120
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Rancho Dominguez, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.