The following data is part of a premarket notification filed by Acmi Corporation with the FDA for Uropass Ureteral Access Sheath, Model 61224.
| Device ID | K051593 |
| 510k Number | K051593 |
| Device Name: | UROPASS URETERAL ACCESS SHEATH, MODEL 61224 |
| Classification | Accessories, Catheter, G-u |
| Applicant | ACMI CORPORATION 136 TURNPIKE RD. Southborough, MA 01772 |
| Contact | Graham Baillie |
| Correspondent | Graham Baillie ACMI CORPORATION 136 TURNPIKE RD. Southborough, MA 01772 |
| Product Code | KNY |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-16 |
| Decision Date | 2005-09-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925035300 | K051593 | 000 |
| 00821925035164 | K051593 | 000 |
| 00821925035171 | K051593 | 000 |
| 00821925035188 | K051593 | 000 |
| 00821925035195 | K051593 | 000 |
| 00821925035201 | K051593 | 000 |
| 00821925035218 | K051593 | 000 |
| 00821925035225 | K051593 | 000 |
| 00821925005976 | K051593 | 000 |
| 00821925005983 | K051593 | 000 |
| 00821925035256 | K051593 | 000 |
| 00821925005990 | K051593 | 000 |
| 00821925035270 | K051593 | 000 |
| 00821925035287 | K051593 | 000 |
| 00821925035294 | K051593 | 000 |
| 00821925035157 | K051593 | 000 |