The following data is part of a premarket notification filed by Spectranetics Corp. with the FDA for Torqmax Sheath Grip Accessory.
| Device ID | K093257 |
| 510k Number | K093257 |
| Device Name: | TORQMAX SHEATH GRIP ACCESSORY |
| Classification | Catheter Introducer Kit |
| Applicant | SPECTRANETICS CORP. 9965 Federal Drive Colorado Springs, CO 80921 |
| Contact | Brandon Hansen |
| Correspondent | Brandon Hansen SPECTRANETICS CORP. 9965 Federal Drive Colorado Springs, CO 80921 |
| Product Code | OFC |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-19 |
| Decision Date | 2010-03-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M204502001AA0 | K093257 | 000 |