← Product Code [MTD](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MTD) · K000277

# CONSTELLATION CATHETERS (K000277)

_Boston Scientific Corp · MTD · Sep 26, 2000 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MTD/K000277

## Device Facts

- **Applicant:** Boston Scientific Corp
- **Product Code:** [MTD](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MTD.md)
- **Decision Date:** Sep 26, 2000
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 870.1220
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MTD/K000277](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MTD/K000277)

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