510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K970714Substantially Equivalent

Stryker Constavac Blood Conservation System II (Cbcii)

Stryker Corp., Kalamazoo MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970714 is the FDA 510(k) clearance record for STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII), a class II device, cleared for Stryker Instruments on under FDA product code CAC (Apparatus, Autotransfusion). FDA records list 568 510(k) clearances for STRYKER CORP., from to . As of , FDA records show 4 recalls naming K970714.

Clearance record

Decision date
Received
(292 days to decision)
Product code
CAC Apparatus, Autotransfusion
Regulation
21 CFR 868.5830
Device class
Class II
Review panel
Anesthesiology
Applicant
Stryker Instruments 4100 E. Milham Ave., Kalamazoo MI
510(k) summary
Summary
Third party review
No

Clearances, product code CAC

Trailing 12 months
1 clearance under product code CAC in the twelve months to October 2026, October 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CAC, 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 20261