Pta, PTV, Atrioseptostomy, Angiographic, Sizing Catheters
FDA 510(k) K040830 · NuMED, Inc.
510(k) numberK040830
Submission
- Device name
- Pta, PTV, Atrioseptostomy, Angiographic, Sizing Catheters
- Applicant
- NuMED, Inc.
Hopkinton, NY, US - Received
- March 31, 2004
- Decision date
- June 18, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
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| K213915 | BIB Stent Placement CatheterNVM · Special | 01/12/2022SE |
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| 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 Pta, PTV, Atrioseptostomy, Angiographic, Sizing Catheters cleared by the FDA?
Pta, PTV, Atrioseptostomy, Angiographic, Sizing Catheters (K040830) received a 510(k) decision of Substantially Equivalent on June 18, 2004, 79 days after the submission was received.
What is the product code of K040830?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.