EP DEFLECTABLE CATHETERS
FDA 510(k) clearance K033963 · decided 2004-04-15
Clearance details
- K-number
- K033963
- Device name
- EP DEFLECTABLE CATHETERS
- Applicant
- Ep Medsystems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-12-22
- Decision date
- 2004-04-15
- Days to decision
- 115 days
- Clearance type
- Special
- Product code
- DRF
- Device class
- 2
- Regulation number
- 870.1220
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- West Berlin, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.