← Product Code [OFC](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OFC) · K093257

# TORQMAX SHEATH GRIP ACCESSORY (K093257)

_Spectranetics Corp. · OFC · Mar 26, 2010 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OFC/K093257

## Device Facts

- **Applicant:** Spectranetics Corp.
- **Product Code:** [OFC](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OFC.md)
- **Decision Date:** Mar 26, 2010
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1340
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OFC/K093257](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OFC/K093257)

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