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 |