PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT)
FDA 510(k) clearance K051067 · decided 2005-05-27
Clearance details
- K-number
- K051067
- Device name
- PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT)
- Applicant
- LeMaitre Vascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-04-26
- Decision date
- 2005-05-27
- Days to decision
- 31 days
- Clearance type
- Special
- Product code
- MJN
- Device class
- 2
- Regulation number
- 870.4450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Bedford, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
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|---|---|---|
| LeMaitre 9F Pruitt F3 Outlying Carotid Shunt with T-port The Pruitt F3 Carotid Shunt (the recall (Z-0070-2012) | Lemaitre Vascular, Inc. | 2011-10-19 |
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|---|---|---|
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