510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K052738Substantially Equivalent

Infusioncath Peripheral Infusion Catheter, Models Vf0012, Vf0016, Vf0024, Vf0028, Vf0032, Vf0036, Vf0040, Vf0044

Veinrx, Inc., Miami FL / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K052738 is the FDA 510(k) clearance record for INFUSIONCATH PERIPHERAL INFUSION CATHETER, MODELS VF0012, VF0016, VF0024, VF0028, VF0032, VF0036, VF0040, VF0044, a class II device, cleared for Veinrx, Inc. on under FDA product code KRA (Catheter, Continuous Flush). FDA records list 2 510(k) clearances for Veinrx, Inc., from to . As of , FDA records show no recalls naming K052738.

Clearance record

Decision date
Received
(67 days to decision)
Product code
KRA Catheter, Continuous Flush
Regulation
21 CFR 870.1210
Device class
Class II
Review panel
Cardiovascular
Applicant
Veinrx, Inc. 8200 NW 27th St., Suite 102, Miami FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KRA

Trailing 12 months
5 clearances under product code KRA in the twelve months to October 2026, September 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KRA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20261
July 20260
August 20260
September 20262
October 20260