24CM POURCHEZ XPRESSO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS
FDA 510(k) clearance K021212 · decided 2002-05-17
Clearance details
- K-number
- K021212
- Device name
- 24CM POURCHEZ XPRESSO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS
- Applicant
- Spire Biomedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-04-17
- Decision date
- 2002-05-17
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- MSD
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Bedford, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.