The following data is part of a premarket notification filed by Electro-catheter Corp. with the FDA for Tip Deflector (genesis).
| Device ID | K943257 |
| 510k Number | K943257 |
| Device Name: | TIP DEFLECTOR (GENESIS) |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | ELECTRO-CATHETER CORP. 2100 FELVER CT. Rahway, NJ 07065 |
| Contact | Lorraine T Montemurro |
| Correspondent | Lorraine T Montemurro ELECTRO-CATHETER CORP. 2100 FELVER CT. Rahway, NJ 07065 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-06 |
| Decision Date | 1995-04-19 |