Scoutpro Acs

FDA 510(k) K101776 · Biotronik, Inc.

Substantially Equivalent

510(k) numberK101776

Submission

Device name
Scoutpro Acs
Applicant
Biotronik, Inc.
Lake Oswego, OR, US
Received
June 25, 2010
Decision date
July 23, 2010
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) statement available from FDA

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 Scoutpro Acs cleared by the FDA?

Scoutpro Acs (K101776) received a 510(k) decision of Substantially Equivalent on July 23, 2010, 28 days after the submission was received.

What is the product code of K101776?

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