Torque Control Balloon Catheter
FDA 510(k) K802338 · Cordis Corp.
510(k) numberK802338
Submission
- Device name
- Torque Control Balloon Catheter
- Applicant
- Cordis Corp.
Mchenry, IL, US - Received
- September 26, 1980
- Decision date
- October 10, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DYG – Catheter, Flow Directed
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1240
- Specialty
- Cardiovascular
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|---|---|---|---|
| K242451 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…DYG · Traditional | Edwards Lifesciences | 12/09/2024SE |
| K233983 | Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5)…DYG · Traditional | Edwards Lifesciences | 06/27/2024SE |
| K233824 | Swan-Ganz catheterDYG · Traditional | Edwards Lifesciences, LLC | 06/06/2024SE |
| K231248 | Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…DYG · Traditional | Edwards Lifesciencess, LLC | 09/21/2023SE |
| K222117 | Swang-Ganz IQ pulmonary artery catheterDYG · Traditional | Edwards Lifesiences, LLC | 12/09/2022SE |
| K193466 | Swan-Ganz CathetersDYG · Traditional | Edwards Lifesciences, LLC | 02/16/2020SE |
| K160084 | Swan Ganz CathetersDYG · Traditional | Edwards Lifesciences, LLC | 05/03/2016SE |
| K094048 | Percupro Messenger Balloon CatheterDYG · Traditional | Cardiosolutions, Inc. | 07/14/2011SE |
| K081052 | Occlusion Balloon Catheter, Model VenosDYG · Traditional | Oscor, Inc. | 06/18/2008SE |
| K010253 | Angio Flow Thermodilution Catheter, Model AF-CATH-01; Angioflow Meter, Models HQ100 and…DYG · Traditional | Transonic Systems, Inc. | 03/19/2002SE |
More from Transonic Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| 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 Torque Control Balloon Catheter cleared by the FDA?
Torque Control Balloon Catheter (K802338) received a 510(k) decision of Substantially Equivalent on October 10, 1980, 14 days after the submission was received.
What is the product code of K802338?
The FDA product code is DYG – Catheter, Flow Directed, a Class II (moderate risk) device regulated under 21 CFR 870.1240.