The following data is part of a premarket notification filed by Greatbatch Medical with the FDA for Optiseal Enpath Valved Ptfe Peelable Introducer.
| Device ID | K093232 |
| 510k Number | K093232 |
| Device Name: | OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | Greatbatch Medical 2300 BERKSHIRE LANE NORTH Minneapolis, MN 55441 |
| Contact | Shannon Springer |
| Correspondent | Shannon Springer Greatbatch Medical 2300 BERKSHIRE LANE NORTH Minneapolis, MN 55441 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-14 |
| Decision Date | 2010-03-15 |
| Summary: | summary |