Cleared Traditional

K953118 - CARACELL (FDA 510(k) Clearance)

K953118 · Medtronic Vascular · Anesthesiology device

Feb 1996

Decision

235d

Days

Class 2

Risk

K953118 is an FDA 510(k) clearance for the CARACELL. This device is classified as a Apparatus, Autotransfusion (Class II - Special Controls, product code CAC).

Submitted by Medtronic Vascular (Parker, US). The FDA issued a Cleared decision on February 23, 1996, 235 days after receiving the submission on July 3, 1995.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5830.

Submission Details

510(k) Number	K953118 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 03, 1995
Decision Date	February 23, 1996
Days to Decision	235 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement