UNBALLOON NON-OCCLUSIVE MODELING CATHETER
FDA 510(k) clearance K121839 · decided 2012-08-08
Clearance details
- K-number
- K121839
- Device name
- UNBALLOON NON-OCCLUSIVE MODELING CATHETER
- Applicant
- LeMaitre Vascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-06-22
- Decision date
- 2012-08-08
- Days to decision
- 47 days
- Clearance type
- Special
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Burlington, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
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|---|---|---|
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| Artegraft Collagen Vascular Graft (N16837/S031) | LeMaitre Vascular, Inc. | 2023-06-29 |
| Artegraft Collagen Vascular Graft (N16837/S030) | LeMaitre Vascular, Inc. | 2023-04-25 |
| Artegraft Collagen Vascular Graft (N16837/S029) | LeMaitre Vascular, Inc. | 2023-01-25 |