Kaplan-Simpson Infusasleeve II

FDA 510(k) K980957 · Localmed, Inc.

Substantially Equivalent

510(k) numberK980957

Submission

Device name
Kaplan-Simpson Infusasleeve II
Applicant
Localmed, Inc.
Palo Alto, CA, US
Received
March 16, 1998
Decision date
June 10, 1998
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.

Other 510(k)s with product code QEY

510(k)DeviceApplicantDecision
K260149Versus™ Catheter (VS110-9NB)QEY · Special Liquet Medical, Inc.02/17/2026SE
K251318VariFuse Adjustable Infusion CatheterQEY · Traditional Argon Medical Devices, Inc.01/20/2026SE
K241851Versus™ Catheter (VS110-8B)QEY · Traditional Liquet Medical, Inc.11/25/2024SE
K231653BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular CatheterQEY · Special Thrombolex, Inc.07/03/2023SE
K222095BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No.…QEY · Traditional Thrombolex, Inc.04/20/2023SE
K220866EKOS+ Endovascular DeviceQEY · Special Boston Scientific04/20/2022SE
K213422EkoSonic Endovascular Device, EKOS+ Endovascular DeviceQEY · Traditional Boston Scientific Corporation12/14/2021SE
K211080EkoSonic Endovascular DeviceQEY · Traditional Boston Scientific11/19/2021SE
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
K972175Infusasleeve Iia (IS-2A)QEY · Traditional 08/28/1997SE
K952317Kaplan-Simpson InfusaSleeve II CatheterQEY · Traditional 06/28/1995SE
K950615Kaplan-Simpson Infusasleeve CatheterQEY · Traditional 04/19/1995SE
K935349Localmed Infusion CatheterKRA · Traditional 10/18/1994SE

Questions and answers

When was Kaplan-Simpson Infusasleeve II cleared by the FDA?

Kaplan-Simpson Infusasleeve II (K980957) received a 510(k) decision of Substantially Equivalent on June 10, 1998, 86 days after the submission was received.

What is the product code of K980957?

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