The following data is part of a premarket notification filed by J-lloyd Medical, Inc. with the FDA for Hexapolar Electrode Balloon Flotation Catheter.
| Device ID | K971504 |
| 510k Number | K971504 |
| Device Name: | HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | J-LLOYD MEDICAL, INC. 415 COMMERCE LANE, SUITE 7 West Berlin, NJ 08091 |
| Contact | James L Skaggs |
| Correspondent | James L Skaggs J-LLOYD MEDICAL, INC. 415 COMMERCE LANE, SUITE 7 West Berlin, NJ 08091 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-25 |
| Decision Date | 1998-04-20 |
| Summary: | summary |