The following data is part of a premarket notification filed by Acme-monaco Corp. with the FDA for Slidewiretm(trademark Pending).
| Device ID | K113162 |
| 510k Number | K113162 |
| Device Name: | SLIDEWIRETM(TRADEMARK PENDING) |
| Classification | Wire, Guide, Catheter |
| Applicant | ACME-MONACO CORP. 75 WINCHELL DR. New Britain, CT 06052 |
| Contact | Benjamin Sweeney |
| Correspondent | Benjamin Sweeney ACME-MONACO CORP. 75 WINCHELL DR. New Britain, CT 06052 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-26 |
| Decision Date | 2012-07-20 |
| Summary: | summary |