← Product Code [DTL](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTL) · K945461

# PITON(TM) Y-PACK AND PITON(TM) TRI-PACK) (K945461)

_Medtronics Interventional Vascular · DTL · Feb 3, 1995 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTL/K945461

## Device Facts

- **Applicant:** Medtronics Interventional Vascular
- **Product Code:** [DTL](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTL.md)
- **Decision Date:** Feb 3, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.4290
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTL/K945461](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTL/K945461)

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