510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K951247Substantially Equivalent

Spiralgold & Spiraloxy Hollow Fiber Oxygenators

Baxter Healthcare Corporation, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K951247 is the FDA 510(k) clearance record for SPIRALGOLD & SPIRALOXY HOLLOW FIBER OXYGENATORS, a class II device, cleared for Baxter Healthcare Corp on under FDA product code DTZ (Oxygenator, Cardiopulmonary Bypass). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K951247.

Clearance record

Decision date
Received
(227 days to decision)
Product code
DTZ Oxygenator, Cardiopulmonary Bypass
Regulation
21 CFR 870.4350
Device class
Class II
Review panel
Cardiovascular
Applicant
Baxter Healthcare Corp 17511 Armstrong Ave., Irvine CA
510(k) summary
Summary
Third party review
No

Clearances, product code DTZ

Trailing 12 months
4 clearances under product code DTZ in the twelve months to November 2026, March 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code DTZ, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20262
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260
November 20260