MEDEGEN PRESSURE RATED EXTENSION SETS
FDA 510(k) clearance K083472 · decided 2008-12-09
Clearance details
- K-number
- K083472
- Device name
- MEDEGEN PRESSURE RATED EXTENSION SETS
- Applicant
- Medegen, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-11-24
- Decision date
- 2008-12-09
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Ontario, CA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus Ext S recall (Z-2941-2026) | BD SWITZERLAND SARL | 2026-08-13 |