The following data is part of a premarket notification filed by Devon Medical Products with the FDA for Cirona 6300 Disposable Deep Vein Thrombosis (dvt) Prevention System.
| Device ID | K151189 |
| 510k Number | K151189 |
| Device Name: | Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention System |
| Classification | Sleeve, Limb, Compressible |
| Applicant | Devon Medical Products 1100 First Avenue, Suite 202 King Of Prussia, PA 19406 |
| Contact | Rocco Bravoco |
| Correspondent | Steve Xu Devon Medical Products 1100 First Avenue, Suite 202 King Of Prussia, PA 19406 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-04 |
| Decision Date | 2015-09-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20879766005444 | K151189 | 000 |