Cordis Endeavor Infusion Catheter
FDA 510(k) K970842 · Cordis Corp.
510(k) numberK970842
Submission
- Device name
- Cordis Endeavor Infusion Catheter
- Applicant
- Cordis Corp.
Miami Lakes, FL, US - Received
- March 7, 1997
- Decision date
- May 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.
Other 510(k)s with product code QEY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
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| K220654 | ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture GuidewireNTE · Special | 04/06/2022SE |
| K212977 | SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbandsDQO · Traditional | 02/17/2022SE |
| K210626 | SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation CatheterLIT · Traditional | 04/23/2021SE |
| K202167 | Brite Tip Radianz Guiding SheathDYB · Traditional | 02/26/2021SE |
| K201377 | SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation CatheterLIT · Traditional | 10/09/2020SE |
| K201333 | SABER .035 PTA Dilatation CatheterLIT · Traditional | 09/11/2020SE |
| K181592 | RAIN Sheath TransradialDYB · Traditional | 08/15/2018SE |
| K180081 | RAILWAY Sheathless Access SystemDYB · Traditional | 04/18/2018SE |
| K143412 | ADROIT Guiding CatheterDQY · Special | 01/14/2015SE |
| K133843 | Saber Percutaneous Transluminal Angioplasty Dilatation CatheterLIT · Traditional | 06/27/2014SE |
Questions and answers
When was Cordis Endeavor Infusion Catheter cleared by the FDA?
Cordis Endeavor Infusion Catheter (K970842) received a 510(k) decision of Substantially Equivalent on May 28, 1997, 82 days after the submission was received.
What is the product code of K970842?
The FDA product code is QEY – Mechanical Thrombolysis Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.5150.