DUAL FUNCTION PACING WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD
FDA 510(k) clearance K950440 · decided 1995-09-15
Clearance details
- K-number
- K950440
- Device name
- DUAL FUNCTION PACING WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD
- Applicant
- J-Lloyd Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-01-27
- Decision date
- 1995-09-15
- Days to decision
- 231 days
- Clearance type
- Traditional
- Product code
- DQO
- Device class
- 2
- Regulation number
- 870.1200
- 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.