510(k) K093257
K093257 is an FDA 510(k) premarket notification submitted by Spectranetics Corp. for the device "TORQMAX SHEATH GRIP ACCESSORY". The FDA issued a decision of Substantially Equivalent on March 26, 2010. The device falls under product code OFC (Catheter Introducer Kit), a Class II device regulated under 21 CFR 870.1340. Spectranetics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 26, 2010
- Date Received
- October 19, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter Introducer Kit
- Device Class
- Class II
- Regulation Number
- 870.1340
- Review Panel
- CV
- Submission Type
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.