Myo/Clip

FDA 510(k) K821518 · Alto Development Corp.

Substantially Equivalent

510(k) numberK821518

Submission

Device name
Myo/Clip
Applicant
Alto Development Corp.
Mchenry, IL, US
Received
May 21, 1982
Decision date
July 8, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LDF – Electrode, Pacemaker, Temporary
Device class
Class II (moderate risk)
Regulation
21 CFR 870.3680
Specialty
Cardiovascular
Life-sustaining
Yes

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K884783Raney ClipFZQ · Traditional 11/30/1988SE
K881413Electro-Cautery Suction TubeGEI · Traditional 04/21/1988SE
K831867Pressure Monitoring IV Bottle CapDRS · Traditional 08/12/1983SE

Questions and answers

When was Myo/Clip cleared by the FDA?

Myo/Clip (K821518) received a 510(k) decision of Substantially Equivalent on July 8, 1982, 48 days after the submission was received.

What is the product code of K821518?

The FDA product code is LDF – Electrode, Pacemaker, Temporary, a Class II (moderate risk) device regulated under 21 CFR 870.3680.