510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K061356Substantially Equivalent

Polyurethane Infusion Catheter, Alpha Cath, Model Pac20, and Polyurethane Infusion Catheter, Multi Drip, Model Pmd20-6

Advanced Infusion, Inc., Tempe AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061356 is the FDA 510(k) clearance record for POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INFUSION CATHETER, MULTI DRIP, MODEL PMD20-6, a class II device, cleared for Advanced Infusion, Inc. on under FDA product code MED (Sterilant, Medical Devices). FDA records list 6 510(k) clearances for Advanced Infusion, Inc., from to . As of , FDA records show no recalls naming K061356.

Clearance record

Decision date
Received
(49 days to decision)
Product code
MED Sterilant, Medical Devices
Regulation
21 CFR 880.6885
Device class
Class II
Review panel
General Hospital
Applicant
Advanced Infusion, Inc. 920 E. University Dr., Tempe AZ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MED

Trailing 12 months
1 clearance under product code MED in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MED, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260