510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163618Unknown

INDIGO Aspiration System

Penumbra Inc., Alameda CA / Traditional, Unknown
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163618 is the FDA 510(k) clearance record for INDIGO Aspiration System, a class II device, cleared for Penumbra, Inc. on under FDA product code QEX (Coronary Mechanical Thrombectomy With Aspiration). FDA's definition for product code QEX reads: "To mechanically disrupt thrombus and/or debris prior to removal from the coronary vasculature through aspiration". FDA records list 87 510(k) clearances for Penumbra, Inc., from to . As of , FDA records show no recalls naming K163618.

Clearance record

Decision date
Received
(153 days to decision)
Product code
QEX Coronary Mechanical Thrombectomy With Aspiration
Regulation
21 CFR 870.5150
Device class
Class II
Review panel
Cardiovascular
Applicant
Penumbra, Inc. One Penumbra Pl., Alameda CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QEX

Trailing 12 months
1 clearance under product code QEX in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QEX, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260