510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K960312Substantially Equivalent

Rdi Cardiac Insulation Pad

R D Intl., Richardson TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960312 is the FDA 510(k) clearance record for RDI CARDIAC INSULATION PAD, a class II device, cleared for R D Intl. on under FDA product code DWP (Dilator, Vessel, Surgical). FDA records list 2 510(k) clearances for R D Intl., from to . As of , FDA records show no recalls naming K960312.

Clearance record

Decision date
Received
(88 days to decision)
Product code
DWP Dilator, Vessel, Surgical
Regulation
21 CFR 870.4475
Device class
Class II
Review panel
Cardiovascular
Applicant
R D Intl. 304 Arborcrest, Richardson TX
510(k) summary
Summary
Third party review
No

Clearances, product code DWP

Trailing 12 months

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

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