510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K160747Substantially Equivalent

Angel Catheter

Bio2 Medical, Inc., Golden CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K160747 is the FDA 510(k) clearance record for Angel Catheter, a class II device, cleared for Bio2 Medical, Inc. on under FDA product code PNS (Short-Term Intravascular Filter Catheter). FDA's definition for product code PNS reads: "For short-term prevention of pulmonary embolism (PE)". FDA records list one 510(k) clearance for Bio2 Medical, Inc. As of , FDA records show no recalls naming K160747.

Clearance record

Decision date
Received
(132 days to decision)
Product code
PNS Short-Term Intravascular Filter Catheter
Regulation
21 CFR 870.3375
Device class
Class II
Review panel
Cardiovascular
Applicant
Bio2 Medical, Inc. 4670 Table Mountain Dr., Golden CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PNS

Trailing 12 months

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

FDA records show no clearances under product code PNS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PNS, 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