The following data is part of a premarket notification filed by Ebi, L.p. with the FDA for Modification To Ebi Targetcath Fluoro-guided Steerable Catheter System.
| Device ID | K032390 |
| 510k Number | K032390 |
| Device Name: | MODIFICATION TO EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM |
| Classification | Catheter, Conduction, Anesthetic |
| Applicant | EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Contact | Barry Sands |
| Correspondent | Barry Sands EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Product Code | BSO |
| CFR Regulation Number | 868.5120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-04 |
| Decision Date | 2003-08-29 |
| Summary: | summary |