Lead Stylet

FDA 510(k) K905674 · Cardiac Pacemakers, Inc.

Substantially Equivalent

510(k) numberK905674

Submission

Device name
Lead Stylet
Applicant
Cardiac Pacemakers, Inc.
St. Paul, MN, US
Received
December 18, 1990
Decision date
January 30, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DRB – Stylet, Catheter
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1380
Specialty
Cardiovascular

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K900498Modified Betatron IV Insulin Infusion SystemLZG · Traditional 02/23/1990SE
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Questions and answers

When was Lead Stylet cleared by the FDA?

Lead Stylet (K905674) received a 510(k) decision of Substantially Equivalent on January 30, 1991, 43 days after the submission was received.

What is the product code of K905674?

The FDA product code is DRB – Stylet, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1380.