SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17; 21G MODEL# 4910-18
FDA 510(k) clearance K992471 · decided 1999-10-22
Clearance details
- K-number
- K992471
- Device name
- SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17; 21G MODEL# 4910-18
- Applicant
- Sims Portex, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-07-26
- Decision date
- 1999-10-22
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- BSO
- Device class
- 2
- Regulation number
- 868.5120
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Keene, NH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.