MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE
FDA 510(k) clearance K132928 · decided 2014-01-23
Clearance details
- K-number
- K132928
- Device name
- MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE
- Applicant
- Medrad, Inc. / Bayer Medical Care, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-09-18
- Decision date
- 2014-01-23
- Days to decision
- 127 days
- Clearance type
- Special
- Product code
- DXT
- Device class
- 2
- Regulation number
- 870.1650
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Indianola, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Ve recall (Z-2775-2015) | Bayer Healthcare | 2015-09-16 |