The following data is part of a premarket notification filed by Angiodynamics with the FDA for Angiovac Circuit.
| Device ID | K142607 |
| 510k Number | K142607 |
| Device Name: | AngioVac Circuit |
| Classification | Tubing, Pump, Cardiopulmonary Bypass |
| Applicant | ANGIODYNAMICS 26 FOREST STREET Marlborough, MA 01752 |
| Contact | Gary Barrett |
| Correspondent | Gary Barrett ANGIODYNAMICS 26 FOREST STREET Marlborough, MA 01752 |
| Product Code | DWE |
| CFR Regulation Number | 870.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-15 |
| Decision Date | 2014-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H965251990 | K142607 | 000 |
| H965251880 | K142607 | 000 |
| H965251870 | K142607 | 000 |
| 15051684019873 | K142607 | 000 |