Cvis Longview

FDA 510(k) K930311 · Cardiovascular Imaging Systems, Inc.

Substantially Equivalent

510(k) numberK930311

Submission

Device name
Cvis Longview
Applicant
Cardiovascular Imaging Systems, Inc.
Sunnyvale, CA, US
Received
January 21, 1993
Decision date
June 2, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DQO – Catheter, Intravascular, Diagnostic
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1200
Specialty
Cardiovascular

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More from Cordis US Corp

510(k)DeviceDecision
K970049BSC, Sonicath Ultra Imaging Catheter 3.2F/20MHZ(37410/456221 & BSC, Sonicath Ultra…ITX · Traditional 06/20/1997SE
K942231Microview Ii/Microrail II CathetersDQO · Traditional 08/01/1994SE
K933517Automatic Pull Back DeviceDQX · Traditional 10/15/1993SE
K930232Cvis Insight Imaging Guide CatheterDQO · Traditional 07/21/1993SE
K924922Cvis Insight Imaging CatheterDQO · Traditional 06/29/1993SE
K921879Cbis Catheter Pull-Back DeviceDQO · Traditional 07/16/1992SE
K921750Cvis Insight III SystemITX · Traditional 07/13/1992SE
K921631Cvis Insight Imaging Catheter for IntraluminalITX · Traditional 07/02/1992SE
K921148Cvis Insight Catheters for Intracardiac UseITX · Traditional 06/16/1992SE
K921147Cvis Insight Imaging Catheter for Intraluminal UseITX · Traditional 06/16/1992SE

Questions and answers

When was Cvis Longview cleared by the FDA?

Cvis Longview (K930311) received a 510(k) decision of Substantially Equivalent on June 2, 1993, 132 days after the submission was received.

What is the product code of K930311?

The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.