AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
FDA 510(k) clearance K042624 · decided 2005-01-10
Clearance details
- K-number
- K042624
- Device name
- AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
- Applicant
- Invatec Innovative Technologies, S.R.L.
- Decision
- Substantially Equivalent
- Date received
- 2004-09-27
- Decision date
- 2005-01-10
- Days to decision
- 105 days
- Clearance type
- Traditional
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Amphirion Deep OTW PTA Balloon Catheter: Model numbers: US: AMP015020152 AMP020150152 AMP0 recall (Z-0243-2016) | Medtronic Vascular, Inc. | 2015-11-06 |