The following data is part of a premarket notification filed by Circulator Boot Corp. with the FDA for Circulator Miniboot.
| Device ID | K833627 |
| 510k Number | K833627 |
| Device Name: | CIRCULATOR MINIBOOT |
| Classification | Device, Counter-pulsating, External |
| Applicant | CIRCULATOR BOOT CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DRN |
| CFR Regulation Number | 870.5225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-14 |
| Decision Date | 1984-05-23 |