Park Blade Septostomy Catheter
FDA 510(k) K182399 · Cook Incorporated
510(k) numberK182399
Submission
- Device name
- Park Blade Septostomy Catheter
- Applicant
- Cook Incorporated
Bloomington, IN, US - Received
- September 4, 2018
- Decision date
- April 4, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
Other 510(k)s with product code DXF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261745 | LightningWire Transseptal Puncture System (TPS)DXF · Traditional | ElectroWire Medical | 06/26/2026SE |
| K253799 | SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135…DXF · Special | Pressure Products Medical Device Manufacturing… | 03/13/2026SE |
| K260292 | Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX)DXF · Special | Atraverse Medical | 02/27/2026SE |
| K252419 | Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX)DXF · Traditional | Atraverse Medical, Inc. | 08/27/2025SE |
| 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 |
|---|---|---|
| K233177 | Nest VT Vitrification DeviceMQK · Traditional | 03/08/2024SE |
| K222254 | Gunther Tulip Vena Cava Filter Retrieval SetMMX · Traditional | 05/16/2023SE |
| K223098 | Bakri Essential Postpartum BalloonOQY · Special | 10/28/2022SE |
| K210734 | Endovascular Dilator and SetsDRE · Special | 04/06/2021SE |
| K203670 | Extra Large Check-Flo IntroducerDYB · Traditional | 02/16/2021SE |
| K191498 | Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane…LJE · Traditional | 01/29/2020SESK |
| K190903 | Lawson Retrograde Nephrostomy Wire Puncture SetLJE · Traditional | 12/16/2019SE |
| K193133 | Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi…JOH · Special | 12/12/2019SE |
| K191163 | Lumax Guiding CatheterDQY · Traditional | 12/12/2019SE |
| K190084 | McLean-Ring Enteral Feeding Tube SetKNT · Traditional | 10/11/2019SE |
Questions and answers
When was Park Blade Septostomy Catheter cleared by the FDA?
Park Blade Septostomy Catheter (K182399) received a 510(k) decision of Substantially Equivalent on April 4, 2019, 212 days after the submission was received.
What is the product code of K182399?
The FDA product code is DXF – Catheter, Septostomy, a Class II (moderate risk) device regulated under 21 CFR 870.5175.