Modification to Ivs Introducer Set, Model 1003

FDA 510(k) K031583 · Integrated Vascular Systems, Inc.

Substantially Equivalent

510(k) numberK031583

Submission

Device name
Modification to Ivs Introducer Set, Model 1003
Applicant
Integrated Vascular Systems, Inc.
Sunnyvale, CA, US
Received
May 21, 2003
Decision date
June 16, 2003
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DYB – Introducer, Catheter
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1340
Specialty
Cardiovascular

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More from Protaryx Medical, Inc.

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K030723Ivs Introducer Set, Model 1003DYB · Traditional 04/03/2003SE
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Questions and answers

When was Modification to Ivs Introducer Set, Model 1003 cleared by the FDA?

Modification to Ivs Introducer Set, Model 1003 (K031583) received a 510(k) decision of Substantially Equivalent on June 16, 2003, 26 days after the submission was received.

What is the product code of K031583?

The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.