The following data is part of a premarket notification filed by Applied Medical Resources with the FDA for Acucise Guidewire Exchange Sheath.
| Device ID | K941010 |
| 510k Number | K941010 |
| Device Name: | ACUCISE GUIDEWIRE EXCHANGE SHEATH |
| Classification | Catheter, Ureteral, Gastro-urology |
| Applicant | APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills, CA 92653 |
| Contact | Richard A Basler |
| Correspondent | Richard A Basler APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills, CA 92653 |
| Product Code | EYB |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-03 |
| Decision Date | 1994-04-18 |