Nephrostomy/Biliary Drainage Bag
FDA 510(k) K834476 · Vertex Medical Corp.
510(k) numberK834476
Submission
- Device name
- Nephrostomy/Biliary Drainage Bag
- Applicant
- Vertex Medical Corp.
Mchenry, IL, US - Received
- December 20, 1983
- Decision date
- February 4, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LJE – Catheter, Nephrostomy
- Device class
- Unclassified
Other 510(k)s with product code LJE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250448 | Disposable Percutaneous Nephrostomy Dilatation KitLJE · Traditional | Shenzhen Trious Medical Technology Co., Ltd. | 07/03/2025SE |
| K222705 | Introducer NeedleLJE · Traditional | Youcare Technology Co.,Ltd. (Wuhan) | 05/22/2023SE |
| K211911 | Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits…LJE · Traditional | Coloplast Corp. | 03/10/2022SESK |
| K201165 | In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz SheathLJE · Traditional | Coloplast Corp. | 12/17/2020SESK |
| K191498 | Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane…LJE · Traditional | Cook Incorporated | 01/29/2020SESK |
| K190903 | Lawson Retrograde Nephrostomy Wire Puncture SetLJE · Traditional | Cook Incorporated | 12/16/2019SE |
| K183051 | Kaye Nephrostomy Tamponade Balloon Catheter and Stent SetLJE · Traditional | Cook Incorporated | 07/16/2019SESK |
| K183035 | Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar NeedleLJE · Traditional | Cook Incorporated | 05/17/2019SESK |
| K181735 | Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent SetLJE · Traditional | Cook Incorporated | 03/27/2019SESK |
| K181713 | Ultraxx Nephrostomy Balloon Catheter SetLJE · Traditional | Cook Incorporated | 08/17/2018SE |
More from Cook Incorporated
| 510(k) | Device | Decision |
|---|---|---|
| K833742 | Eschmann Dilation Catheter · Traditional | 04/24/1984SE |
| K832380 | Protective SleeveDYG · Traditional | 11/28/1983SE |
| K831666 | Sialography Needle · Traditional | 07/12/1983SE |
| K830576 | Lymphangiography SetDQO · Traditional | 03/17/1983SE |
| K830420 | Polyethylene Monitoring ConnectorsDQO · Traditional | 02/28/1983SE |
| K830237 | Translucent Poly. Cath. Connector andDQO · Traditional | 02/18/1983SE |
| K823340 | Clear Vinyl Monitoring ConnectorDXT · Traditional | 12/30/1982SE |
| K823256 | Ultra-Asept Angiographic Syringe/SpareDXT · Traditional | 12/30/1982SE |
| K823254 | Reusable Metal StopcockDXT · Traditional | 12/30/1982SE |
| K823253 | Vertex Monitoring CatheterDXT · Traditional | 12/30/1982SE |
Questions and answers
When was Nephrostomy/Biliary Drainage Bag cleared by the FDA?
Nephrostomy/Biliary Drainage Bag (K834476) received a 510(k) decision of Substantially Equivalent on February 4, 1984, 46 days after the submission was received.
What is the product code of K834476?
The FDA product code is LJE – Catheter, Nephrostomy, a Unclassified device.