Modified Numed Balloon Angiographic Catheter
FDA 510(k) K883948 · NuMED, Inc.
510(k) numberK883948
Submission
- Device name
- Modified Numed Balloon Angiographic Catheter
- Applicant
- NuMED, Inc.
Hopkinton, NY, US - Received
- September 13, 1988
- Decision date
- April 21, 1989
- 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 |
|---|---|---|
| K213915 | BIB Stent Placement CatheterNVM · Special | 01/12/2022SE |
| K211910 | Z-6 Atrioseptostomy CatheterDXF · Special | 07/19/2021SE |
| K211134 | BIB Stent Placement CatheterNVM · Special | 05/27/2021SE |
| K190974 | D'Vill IntroducerDYB · Special | 05/14/2019SE |
| K171206 | D'Vill IntroducerDYB · Traditional | 10/20/2017SE |
| K161451 | BIB Stent Placement CatheterNVM · Traditional | 09/22/2016SE |
| K160598 | REBOA Balloon CatheterMJN · Traditional | 06/20/2016SE |
| K160889 | BIB Stent Placement CatheterNVM · Traditional | 05/20/2016SE |
| K131869 | Pts-X Sizing Balloon CatheterMJN · Special | 08/08/2013SE |
| K122012 | Z-Med Z-Med IIOZT · Traditional | 10/04/2012SE |
Questions and answers
When was Modified Numed Balloon Angiographic Catheter cleared by the FDA?
Modified Numed Balloon Angiographic Catheter (K883948) received a 510(k) decision of Substantially Equivalent on April 21, 1989, 220 days after the submission was received.
What is the product code of K883948?
The FDA product code is DYG – Catheter, Flow Directed, a Class II (moderate risk) device regulated under 21 CFR 870.1240.