510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K994194Substantially Equivalent

(Tas) Low Range Heparin Management Card Rapidpoint

Cardiovascular Diagnostics, Inc., Raleigh NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K994194 is the FDA 510(k) clearance record for (TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT, a class II device, cleared for Cardiovascular Diagnostics, Inc. on under FDA product code JBP (Activated Whole Blood Clotting Time). FDA records list 13 510(k) clearances for Cardiovascular Diagnostics, Inc., from to . As of , FDA records show no recalls naming K994194.

Clearance record

Decision date
Received
(106 days to decision)
Product code
JBP Activated Whole Blood Clotting Time
Regulation
21 CFR 864.7140
Device class
Class II
Review panel
Hematology
Applicant
Cardiovascular Diagnostics, Inc. 5301 Departure Dr., Raleigh NC
510(k) summary
Summary
Third party review
No

Clearances, product code JBP

Trailing 12 months

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

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