Beta-Cap II Adapter

FDA 510(k) K801680 · Quinton, Inc.

Substantially Equivalent

510(k) numberK801680

Submission

Device name
Beta-Cap II Adapter
Applicant
Quinton, Inc.
Mchenry, IL, US
Received
July 22, 1980
Decision date
August 4, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GCE – Adaptor, Catheter
Device class
Class I (low risk)
Regulation
21 CFR 878.4200
Specialty
General, Plastic Surgery

Other 510(k)s with product code GCE

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K901716Klein Connector(Tm)GCE · Traditional Jeff Klein Surgical, Inc.05/11/1990SE
K901715Klein Cork(Tm)GCE · Traditional Jeff Klein Surgical, Inc.05/11/1990SE
K855039Mediflex Injection CapGCE · Traditional Mediflex Intl.01/24/1986SE

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Questions and answers

When was Beta-Cap II Adapter cleared by the FDA?

Beta-Cap II Adapter (K801680) received a 510(k) decision of Substantially Equivalent on August 4, 1980, 13 days after the submission was received.

What is the product code of K801680?

The FDA product code is GCE – Adaptor, Catheter, a Class I (low risk) device regulated under 21 CFR 878.4200.