← Product Code [DQY](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY) · K010838

# FOX PTA CATHETER, 3.0, 4.0, 5.0, 6.0, 7.0, AND 8.0 X 40 MM, MODELS A14003, A14004, A14005, A14006, A14007, A14008 (K010838)

_Jomed AG · DQY · Jun 21, 2001 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY/K010838

## Device Facts

- **Applicant:** Jomed AG
- **Product Code:** [DQY](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY.md)
- **Decision Date:** Jun 21, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1250
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY/K010838](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY/K010838)

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