The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Exacta Percutaneous Introducer Sheath.
| Device ID | K941428 |
| 510k Number | K941428 |
| Device Name: | EXACTA PERCUTANEOUS INTRODUCER SHEATH |
| Classification | Introducer, Catheter |
| Applicant | OHMEDA MEDICAL 1911 WILLIAMS DR. Oxnard, CA 93030 -2629 |
| Contact | Cheryl L Shea |
| Correspondent | Cheryl L Shea OHMEDA MEDICAL 1911 WILLIAMS DR. Oxnard, CA 93030 -2629 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-24 |
| Decision Date | 1994-07-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884450321045 | K941428 | 000 |
| 20884450321052 | K941428 | 000 |