Cleared Traditional

K001690 - PROTECTIV SAFETY BLOOD COLLECTION NEEDLE
(FDA 510(k) Clearance)

K001690 · Johnson & Johnson Medical, Inc. · General Hospital

Jul 2000

Decision

59d

Days

Class 2

Risk

K001690 is an FDA 510(k) clearance for the PROTECTIV SAFETY BLOOD COLLECTION NEEDLE. This device is classified as a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI).

Submitted by Johnson & Johnson Medical, Inc. (Arlington, US). The FDA issued a Cleared decision on July 31, 2000, 59 days after receiving the submission on June 2, 2000.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number	K001690 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 02, 2000
Decision Date	July 31, 2000
Days to Decision	59 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF