510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K033085Substantially Equivalent

Portaclamp

Cardio Life Research, S.A., North Attleboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K033085 is the FDA 510(k) clearance record for PORTACLAMP, a class II device, cleared for Cardio Life Research, S.A. on under FDA product code DXC (Clamp, Vascular). FDA records list 2 510(k) clearances for Cardio Life Research, S.A., from to . As of , FDA records show no recalls naming K033085.

Clearance record

Decision date
Received
(211 days to decision)
Product code
DXC Clamp, Vascular
Regulation
21 CFR 870.4450
Device class
Class II
Review panel
Cardiovascular
Applicant
Cardio Life Research, S.A. 49 Plain St., North Attleboro MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DXC

Trailing 12 months
6 clearances under product code DXC 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 DXC, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20261
May 20261
June 20261
July 20261
August 20260
September 20260
October 20260