DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM)
FDA 510(k) clearance K010399 · decided 2001-08-14
Clearance details
- K-number
- K010399
- Device name
- DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM)
- Applicant
- Diatek, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-02-09
- Decision date
- 2001-08-14
- Days to decision
- 186 days
- Clearance type
- Traditional
- Product code
- MSD
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Winston-Salem, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip: 19cm, CS-15242, Inten recall (Z-2242-2008) | Arrow International Inc | 2008-09-17 |
| Cannon catheter hemodialysis catheterization set, 15 Fr x 36 cm recall (Z-0084-04) | Arrow International Inc | 2003-11-01 |