DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM)
FDA 510(k) clearance K032041 · decided 2003-08-27
Clearance details
- K-number
- K032041
- Device name
- DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM)
- Applicant
- LeMaitre Vascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-07-01
- Decision date
- 2003-08-27
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- DWF
- Device class
- 2
- Regulation number
- 870.4210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Bedford, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
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