BAXTER D & C TRAY— 510(k) K901442

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K901442 for BAXTER D & C TRAY, Substantially Equivalent on 1990-07-26. Applicant: Baxter Healthcare Corp. Device class: 1.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code HCY
Device class: Class 1
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1990-03-27
Decision date: 1990-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Niles, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HCY

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K944238 — ENDOCYTE TM1995-09-15
K935822 — PHASE I CURETTE1994-04-28
K890384 — UTERINE CURETTE1989-02-13
K881794 — IVORY FINDER SET1988-07-08

More clearances from Baxter Healthcare Corp

Recalls naming K901442

K-number listed on FDA's recall record

Z-1402-2016 — Catalog Number: 900032 UNIVERSAL DRAINAGE TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.Class II·Terminated·Customed, Inc·20160107

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K901442.

Data sourced from openFDA. This site is unofficial and independent of the FDA.