510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K222185Substantially Equivalent

Stratus Infusion Catheter

Intervene Inc, South San Francisco CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K222185 is the FDA 510(k) clearance record for Stratus Infusion Catheter, a class II device, cleared for Intervene, Inc. on under FDA product code NPG (Catheter, Infusion, Syringe). FDA's definition for product code NPG reads: "To provide physician specified fluids both perivascular or intraluminal to the perivascular space". FDA records list 2 510(k) clearances for Intervene, Inc., from to . As of , FDA records show no recalls naming K222185.

Clearance record

Decision date
Received
(265 days to decision)
Product code
NPG Catheter, Infusion, Syringe
Regulation
21 CFR 870.1210
Device class
Class II
Review panel
Cardiovascular
Applicant
Intervene, Inc. 415 Grand Ave., Suite 302, South San Francisco CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NPG

Trailing 12 months

FDA records hold no clearances under product code NPG in the trailing twelve months.

FDA records show no clearances under product code NPG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NPG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260