MiniCap Extended Life PD Transfer Sets
FDA 510(k) clearance K192705 · decided 2019-10-25
Clearance details
- K-number
- K192705
- Device name
- MiniCap Extended Life PD Transfer Sets
- Applicant
- Baxter Healthcare
- Decision
- Substantially Equivalent
- Date received
- 2019-09-27
- Decision date
- 2019-10-25
- Days to decision
- 28 days
- Clearance type
- Special
- 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 5C4483; use in recall (Z-0562-2025) | Baxter Healthcare Corporation | 2024-11-27 |
| Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in recall (Z-0376-2025) | Baxter Healthcare Corporation | 2024-11-20 |