Pta, PTV, Atrioseptostomy, Angiographic, Sizing Catheters
FDA 510(k) K011557 · NuMED, Inc.
510(k) numberK011557
Submission
- Device name
- Pta, PTV, Atrioseptostomy, Angiographic, Sizing Catheters
- Applicant
- NuMED, Inc.
Hopkinton, NY, US - Received
- May 21, 2001
- Decision date
- July 12, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXF – Catheter, Septostomy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5175
- Specialty
- Cardiovascular
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| K260292 | Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX)DXF · Special | Atraverse Medical | 02/27/2026SE |
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| K251007 | CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C…DXF · Special | Circa Scientific, Inc. | 05/01/2025SE |
| K243193 | Cross Wise Multi-Use RF Adapter CableDXF · Special | Circa Scientific, Inc. | 11/26/2024SE |
| K242076 | VersaCross RF WireDXF · Special | Baylis Medical Company | 11/01/2024SE |
| K241414 | CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C)…DXF · Traditional | Circa Scientific, Inc. | 09/26/2024SE |
| K240900 | HOTWIRE RF GuidewireDXF · Traditional | Atraverse Medical | 05/01/2024SE |
| K232852 | Cross Vascular RF Transseptal Needle, Cross Vascular Connection CableDXF · Traditional | Cross Vascular, Inc. | 10/12/2023SE |
More from Cross Vascular, 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 Pta, PTV, Atrioseptostomy, Angiographic, Sizing Catheters cleared by the FDA?
Pta, PTV, Atrioseptostomy, Angiographic, Sizing Catheters (K011557) received a 510(k) decision of Substantially Equivalent on July 12, 2001, 52 days after the submission was received.
What is the product code of K011557?
The FDA product code is DXF – Catheter, Septostomy, a Class II (moderate risk) device regulated under 21 CFR 870.5175.