Multicath - Code#S 8.1207.OO/8.1208.00/8.1205.20

FDA 510(k) K870067 · Vygon Corp.

Substantially Equivalent

510(k) numberK870067

Submission

Device name
Multicath - Code#S 8.1207.OO/8.1208.00/8.1205.20
Applicant
Vygon Corp.
East Rutherford, NJ, US
Received
January 8, 1987
Decision date
April 28, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DQY – Catheter, Percutaneous
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1250
Specialty
Cardiovascular

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Questions and answers

When was Multicath - Code#S 8.1207.OO/8.1208.00/8.1205.20 cleared by the FDA?

Multicath - Code#S 8.1207.OO/8.1208.00/8.1205.20 (K870067) received a 510(k) decision of Substantially Equivalent on April 28, 1987, 110 days after the submission was received.

What is the product code of K870067?

The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.