VTI INTRAOPERATIVE DOPPLER SYSTEMS— 510(k) K082870

Clearance details

Applicant

Vascular Technology Incorporated

Product code

Code DPW

Device class

Class 2

Regulation

21 CFR 870.2100

Advisory panel

Cardiovascular

Date received

2008-09-29

Decision date

2008-10-28

Decision

Substantially Equivalent

Clearance type

Special

Location

Nashua, NH, US

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• Z-1998-2014 — 07-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4, REF 138200 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.Class II·Terminated·Vascular Technology, Inc.·20140528
• Z-1999-2014 — 07-150-10 MIZUHO, DOPPLER PROBE, SLIM, BX 4, REF 138660 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.Class II·Terminated·Vascular Technology, Inc.·20140528
• Z-2000-2014 — 07-150-12 MIZUHO, MINI, SLIM, STERILE, BOX OF 4, REF 138665 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.Class II·Terminated·Vascular Technology, Inc.·20140528
• Z-2001-2014 — VTI BAYONET DOPPLER, 20MHz DOPPLER PROBE, SLIM, BX 4, REF 108660 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.Class II·Terminated·Vascular Technology, Inc.·20140528

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082870.