Infusasleeve Iia (IS-2A)
FDA 510(k) K972175 · Localmed, Inc.
510(k) numberK972175
Submission
- Device name
- Infusasleeve Iia (IS-2A)
- Applicant
- Localmed, Inc.
Palo Alto, CA, US - Received
- June 9, 1997
- Decision date
- August 28, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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|---|---|---|---|
| K260149 | Versus Catheter (VS110-9NB)QEY · Special | Liquet Medical, Inc. | 02/17/2026SE |
| K251318 | VariFuse Adjustable Infusion CatheterQEY · Traditional | Argon Medical Devices, Inc. | 01/20/2026SE |
| K241851 | Versus Catheter (VS110-8B)QEY · Traditional | Liquet Medical, Inc. | 11/25/2024SE |
| K231653 | BASHIR .035 Endovascular Catheter, BASHIR S-B .035 Endovascular CatheterQEY · Special | Thrombolex, Inc. | 07/03/2023SE |
| K222095 | BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No.…QEY · Traditional | Thrombolex, Inc. | 04/20/2023SE |
| K220866 | EKOS+ Endovascular DeviceQEY · Special | Boston Scientific | 04/20/2022SE |
| K213422 | EkoSonic Endovascular Device, EKOS+ Endovascular DeviceQEY · Traditional | Boston Scientific Corporation | 12/14/2021SE |
| K211080 | EkoSonic Endovascular DeviceQEY · Traditional | Boston Scientific | 11/19/2021SE |
| K211061 | BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref.…QEY · Traditional | Thrombolex, Inc. | 06/10/2021SE |
| K202347 | UNIFUSE Infusion System with Cooper WireQEY · Special | AngioDynamics, Inc. | 09/15/2020SE |
More from AngioDynamics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K980957 | Kaplan-Simpson Infusasleeve IIQEY · Traditional | 06/10/1998SE |
| K952317 | Kaplan-Simpson InfusaSleeve II CatheterQEY · Traditional | 06/28/1995SE |
| K950615 | Kaplan-Simpson Infusasleeve CatheterQEY · Traditional | 04/19/1995SE |
| K935349 | Localmed Infusion CatheterKRA · Traditional | 10/18/1994SE |
Questions and answers
When was Infusasleeve Iia (IS-2A) cleared by the FDA?
Infusasleeve Iia (IS-2A) (K972175) received a 510(k) decision of Substantially Equivalent on August 28, 1997, 80 days after the submission was received.
What is the product code of K972175?
The FDA product code is QEY – Mechanical Thrombolysis Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.5150.