The Circulator Boot

FDA 510(k) K971026 · Circulator Boot Corp.

Substantially Equivalent

510(k) numberK971026

Submission

Device name
The Circulator Boot
Applicant
Circulator Boot Corp.
Ardmore, PA, US
Received
March 20, 1997
Decision date
August 14, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DRN – Device, Counter-Pulsating, External
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5225
Specialty
Cardiovascular

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More from Ecp Health, Inc.

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K082134Circulator BootDRN · Traditional 05/07/2009SE
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Questions and answers

When was The Circulator Boot cleared by the FDA?

The Circulator Boot (K971026) received a 510(k) decision of Substantially Equivalent on August 14, 1997, 147 days after the submission was received.

What is the product code of K971026?

The FDA product code is DRN – Device, Counter-Pulsating, External, a Class II (moderate risk) device regulated under 21 CFR 870.5225.