The following data is part of a premarket notification filed by J-lloyd Medical, Inc. with the FDA for Bipolar Balloon Pacing Catheter By J-lloyd.
| Device ID | K930069 |
| 510k Number | K930069 |
| Device Name: | BIPOLAR BALLOON PACING CATHETER BY J-LLOYD |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | J-LLOYD MEDICAL, INC. 415 COMMERCE LN., SUITE 6 West Berlin, NJ 08091 |
| Contact | James L Skaggs |
| Correspondent | James L Skaggs J-LLOYD MEDICAL, INC. 415 COMMERCE LN., SUITE 6 West Berlin, NJ 08091 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-06 |
| Decision Date | 1994-01-28 |