BIPOLAR BALLOON PACING CATHETER BY J-LLOYD
FDA 510(k) clearance K930069 · decided 1994-01-28
Clearance details
- K-number
- K930069
- Device name
- BIPOLAR BALLOON PACING CATHETER BY J-LLOYD
- Applicant
- J-Lloyd Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-01-06
- Decision date
- 1994-01-28
- Days to decision
- 387 days
- Clearance type
- Traditional
- Product code
- LDF
- Device class
- 2
- Regulation number
- 870.3680
- 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.