← Product Code [QEW](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEW) · K260599

# INDIGO® Aspiration System – INDIGO Link (K260599)

_Penumbra, Inc. · QEW · Apr 24, 2026 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEW/K260599

## Device Facts

- **Applicant:** Penumbra, Inc.
- **Product Code:** [QEW](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEW.md)
- **Decision Date:** Apr 24, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.5150
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEW/K260599](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEW/K260599)

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