EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADAPTER
FDA 510(k) clearance K152675 · decided 2015-10-29
Clearance details
- K-number
- K152675
- Device name
- EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADAPTER
- Applicant
- Baxter Healthcare
- Decision
- Substantially Equivalent
- Date received
- 2015-09-18
- Decision date
- 2015-10-29
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- KDJ
- Device class
- 2
- Regulation number
- 876.5630
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Round Lake, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in recall (Z-0559-2025) | Baxter Healthcare Corporation | 2024-11-27 |
| Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in recall (Z-0373-2025) | Baxter Healthcare Corporation | 2024-11-20 |