DeviceClearance

WALKAWAY TM 40— 510(k) K911400

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K911400 for WALKAWAY TM 40, Substantially Equivalent on 1991-11-19. Applicant: Baxter Healthcare Corp. Device class: 2.

Clearance details

Applicant
Baxter Healthcare Corp
Product code
Code LRG
Device class
Class 2
Regulation
21 CFR 866.1640
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
West Sacramento, CA, US
Download summary PDFView on FDA.gov ↗

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Recalls naming K911400

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K911400.

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