Circulator Miniboot

FDA 510(k) K833627 · Circulator Boot Corp.

Substantially Equivalent

510(k) numberK833627

Submission

Device name
Circulator Miniboot
Applicant
Circulator Boot Corp.
Walker, MI, US
Received
October 14, 1983
Decision date
May 23, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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.

510(k)DeviceDecision
K082134Circulator BootDRN · Traditional 05/07/2009SE
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Questions and answers

When was Circulator Miniboot cleared by the FDA?

Circulator Miniboot (K833627) received a 510(k) decision of Substantially Equivalent on May 23, 1984, 222 days after the submission was received.

What is the product code of K833627?

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