Extension Set
FDA 510(k) clearance K153293 · decided 2016-04-06
Clearance details
- K-number
- K153293
- Device name
- Extension Set
- Applicant
- B.Braun Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-11-13
- Decision date
- 2016-04-06
- Days to decision
- 145 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Allentown, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets recall (Z-0611-2026) | B Braun Medical Inc | 2025-11-26 |
| Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets recall (Z-0612-2026) | B Braun Medical Inc | 2025-11-26 |
| Extension Set utilized in gravity IV administration sets and pump administration sets util recall (Z-0630-2026) | B Braun Medical Inc | 2025-11-26 |
| IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0665-2026) | B Braun Medical Inc | 2025-11-26 |
| IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0669-2026) | B Braun Medical Inc | 2025-11-26 |
| IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0673-2026) | B Braun Medical Inc | 2025-11-26 |
| IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0674-2026) | B Braun Medical Inc | 2025-11-26 |