510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K875117Substantially Equivalent

Ciba Corning Balanced Heparin for Ca++

Ciba Corning Diagnostics Corp., East Walpole MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K875117 is the FDA 510(k) clearance record for CIBA CORNING BALANCED HEPARIN FOR CA++, a class I device, cleared for Ciba Corning Diagnostics Corp. on under FDA product code CBT (Arterial Blood Sampling Kit). FDA's definition for product code CBT reads: "This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the...". FDA records list 125 510(k) clearances for Ciba Corning Diagnostics Corp., from to . As of , FDA records show no recalls naming K875117.

Clearance record

Decision date
Received
(76 days to decision)
Product code
CBT Arterial Blood Sampling Kit
Regulation
21 CFR 868.1100
Device class
Class I
Review panel
Anesthesiology
Applicant
Ciba Corning Diagnostics Corp. 333 Coney St., East Walpole MA
Third party review
No

Clearances, product code CBT

Trailing 12 months

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

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