Interflo Medical Model PA3-H Cco/Pac Catheter
FDA 510(k) K911840 · Intec Medical, Inc.
510(k) numberK911840
Submission
- Device name
- Interflo Medical Model PA3-H Cco/Pac Catheter
- Applicant
- Intec Medical, Inc.
Arlington, VA, US - Received
- April 25, 1991
- Decision date
- June 3, 1991
- 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
Other 510(k)s with product code DYG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K903217 | Tapered Tip the Guider Coronary Guiding CatheterDQY · Traditional | 10/19/1990SE |
| K903216 | The Guider Coronary Guiding CatheterDQY · Traditional | 10/19/1990SE |
| K900710 | Interflo Medical Model F-1 Thermodilution CatheterKRB · Traditional | 10/19/1990SE |
| K903840 | Giant Lumen Safetip Series: Endomyocardial BiopsyDYB · Traditional | 10/16/1990SE |
| K903906 | Percutaneous Catheter Introducer KitDYB · Traditional | 09/26/1990SE |
| K900998 | Interventional Medical Y Adapter W/Adjust. ValveDQY · Traditional | 08/14/1990SE |
| K901247 | Tri Adapter W/Adjustable Hemostasis ValvesDYG · Traditional | 07/31/1990SE |
| K894925 | Amcath Ureteral Dilators Models 7100,7110,7120EZN · Traditional | 12/13/1989SE |
| K860941 | Disposable Heated Wire Loops 48 and 72BZE · Traditional | 04/02/1986SE |
| K823271 | Disposable Adult Vo. Ventilator CircuitBZO · Traditional | 12/22/1982SE |
Questions and answers
When was Interflo Medical Model PA3-H Cco/Pac Catheter cleared by the FDA?
Interflo Medical Model PA3-H Cco/Pac Catheter (K911840) received a 510(k) decision of Substantially Equivalent on June 3, 1991, 39 days after the submission was received.
What is the product code of K911840?
The FDA product code is DYG – Catheter, Flow Directed, a Class II (moderate risk) device regulated under 21 CFR 870.1240.