Kaplan-Simpson InfusaSleeve II Catheter

FDA 510(k) K952317 · Localmed, Inc.

Substantially Equivalent

510(k) numberK952317

Submission

Device name
Kaplan-Simpson InfusaSleeve II Catheter
Applicant
Localmed, Inc.
Palo Alto, CA, US
Received
May 17, 1995
Decision date
June 28, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
QEY – Mechanical Thrombolysis Catheter
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5150
Specialty
Cardiovascular

To mechanically disrupt thrombus and/or debris in the peripheral vasculature.

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K220866EKOS+ Endovascular DeviceQEY · Special Boston Scientific04/20/2022SE
K213422EkoSonic Endovascular Device, EKOS+ Endovascular DeviceQEY · Traditional Boston Scientific Corporation12/14/2021SE
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K211061BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref.…QEY · Traditional Thrombolex, Inc.06/10/2021SE
K202347UNIFUSE Infusion System with Cooper WireQEY · Special AngioDynamics, Inc.09/15/2020SE

More from AngioDynamics, Inc.

510(k)DeviceDecision
K980957Kaplan-Simpson Infusasleeve IIQEY · Traditional 06/10/1998SE
K972175Infusasleeve Iia (IS-2A)QEY · Traditional 08/28/1997SE
K950615Kaplan-Simpson Infusasleeve CatheterQEY · Traditional 04/19/1995SE
K935349Localmed Infusion CatheterKRA · Traditional 10/18/1994SE

Questions and answers

When was Kaplan-Simpson InfusaSleeve II Catheter cleared by the FDA?

Kaplan-Simpson InfusaSleeve II Catheter (K952317) received a 510(k) decision of Substantially Equivalent on June 28, 1995, 42 days after the submission was received.

What is the product code of K952317?

The FDA product code is QEY – Mechanical Thrombolysis Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.5150.