Flow Direct Thermodilut Balloon Cath Heparin Coated
FDA 510(k) K940547 · J-Lloyd Medical, Inc.
510(k) numberK940547
Submission
- Device name
- Flow Direct Thermodilut Balloon Cath Heparin Coated
- Applicant
- J-Lloyd Medical, Inc.
West Berlin, NJ, US - Received
- February 7, 1994
- Decision date
- August 11, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
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| 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 |
|---|---|---|
| K973639 | Electrode Semi-Flotation Catheter by J-Lloyd Medical, Inc.DRF · Traditional | 04/20/1998SE |
| K971504 | Hexapolar Electrode Balloon Flotation CatheterDRF · Traditional | 04/20/1998SE |
| K974336 | Cholangiograph Balloon Catheter by J-Lloyd Medical, Inc.GCJ · Traditional | 02/13/1998SE |
| K974335 | Embolectomy, Irrigation - Occlusion Balloon Catheter by J-Lloyd Medical, Inc.DXE · Traditional | 02/13/1998SE |
| K963248 | Flow Directed Thermodilution/Infusion Balloon Catheter (575-110P)DYG · Traditional | 02/03/1997SE |
| K950440 | Dual Function Pacing Wedge Pressure Balloon Catheter by J-LloydDQO · Traditional | 09/15/1995SE |
| K935405 | Arterial EmbolectomyDXE · Traditional | 07/25/1994SE |
| K935403 | Wedge Pressure Balloon Catheter by J-LloydDQO · Traditional | 05/12/1994SE |
| K935404 | Flow Directed Thermodilution Balloon CatheterDYG · Traditional | 05/03/1994SE |
| K935402 | Angiographic Balloon Catheter by J-LloydDQO · Traditional | 04/26/1994SE |
Questions and answers
When was Flow Direct Thermodilut Balloon Cath Heparin Coated cleared by the FDA?
Flow Direct Thermodilut Balloon Cath Heparin Coated (K940547) received a 510(k) decision of Substantially Equivalent on August 11, 1994, 185 days after the submission was received.
What is the product code of K940547?
The FDA product code is DYG – Catheter, Flow Directed, a Class II (moderate risk) device regulated under 21 CFR 870.1240.