Multi-Snare Set

FDA 510(k) K011783 · Pfm Produkte Fur Die Medizin AG

Substantially Equivalent

510(k) numberK011783

Submission

Device name
Multi-Snare Set
Applicant
Pfm Produkte Fur Die Medizin AG
Trabuco Canyon, CA, US
Received
June 7, 2001
Decision date
January 24, 2002
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DXE – Catheter, Embolectomy
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5150
Specialty
Cardiovascular

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Questions and answers

When was Multi-Snare Set cleared by the FDA?

Multi-Snare Set (K011783) received a 510(k) decision of Substantially Equivalent on January 24, 2002, 231 days after the submission was received.

What is the product code of K011783?

The FDA product code is DXE – Catheter, Embolectomy, a Class II (moderate risk) device regulated under 21 CFR 870.5150.