The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corp. with the FDA for Tenderflow Periatric Arterial Cannula.
Device ID | K063618 |
510k Number | K063618 |
Device Name: | TENDERFLOW PERIATRIC ARTERIAL CANNULA |
Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
Applicant | TERUMO CARDIOVASCULAR SYSTEMS CORP. 6200 JACKSON RD. Ann Arbor, MI 48103 |
Contact | Christina L Thomas |
Correspondent | Christina L Thomas TERUMO CARDIOVASCULAR SYSTEMS CORP. 6200 JACKSON RD. Ann Arbor, MI 48103 |
Product Code | DWF |
CFR Regulation Number | 870.4210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-12-05 |
Decision Date | 2007-03-13 |
Summary: | summary |