510(k) clearances

VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S, VS8-MP90S, VS8-MP100B, VS10-MP100B, VS11-MP60S, VS11-MP90S, VS12-MP100B, 7F-MP60S, 7F-MP90S, 8F-MP60S, 8F-MP100B, 10F-MP100B, 11F-MP60S, 11F-MP90S, 11P-MP60S, 11P-MP90S, 12F-MP100B, V30-ASP)

Control Medical Technology, Inc. / Dba Ventiv Scientific · Cardiovascular

K250013Substantially EquivalentSpecialQEZ
Open FDA's page for this record
Third party flag
N
City
Salt Lake City
Advisory committee description
Cardiovascular
Address 1
2757 S. 300 W. Suite F
Statement or summary
Summary
Product code
QEZ
Zip code
84115
Applicant
Control Medical Technology, Inc. / Dba Ventiv Scientific
Decision date
2025-03-24
Decision code
SESE
Country code
US
Advisory committee
CV
Contact
Shawn Fojtik
K number
K250013
State
UT
Date received
2025-01-02
Review advisory committee
CV
Postal code
84115
Decision description
Substantially Equivalent
Clearance type
Special
Device name

VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S, VS8-MP90S, VS8-MP100B, VS10-MP100B, VS11-MP60S, VS11-MP90S, VS12-MP100B, 7F-MP60S, 7F-MP90S, 8F-MP60S, 8F-MP100B, 10F-MP100B, 11F-MP60S, 11F-MP90S, 11P-MP60S, 11P-MP90S, 12F-MP100B, V30-ASP)

Harmonized identifiers (openFDA)
Device name
Aspiration Thrombectomy Catheter
Medical specialty description
Cardiovascular
Regulation number
870.5150
Device class
2
Registration number
3031788372, 2134265, 3003898360, 1724474, 3008307705, 3012102437, 3012167431, 1000121056, 2124215, 2183870, 2183744, 1000523114, 3013556777, 3019807891, 3015225571, 3009500972, 3017823876, 3031823122, 1721504, 3010273872, 3013162291, 3009613036, 2134812, 2024168, 2024311, 3012536737, 3009756153, 9681260, 2030598, 3011137372, 3033589330, 1064858, 1220452, 1319639, 3007284006, 3040099838, 3006950086, 2032521, 3010220595, 2648729 +9 more
FEI number
3031788372, 3003898360, 3008307705, 3012102437, 3012167431, 1000121056, 3002806565, 2124215, 3003737899, 3003094851, 2183870, 2183744, 1000523114, 3013556777, 3019807891, 3015225571, 3009500972, 3003574398, 3017823876, 3031823122, 1721504, 3010273872, 3013162291, 3009613036, 2024168, 2024311, 3012536737, 3009756153, 3002095335, 3033589330, 3008397795, 3001451463, 1220452, 3007284006, 1000518731, 3002827704, 3006950086, 3010220595, 2648729, 1000138054 +9 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.