Percutaneous Grainage Catheter
FDA 510(k) K943893 · Menlo Care, Inc.
510(k) numberK943893
Submission
- Device name
- Percutaneous Grainage Catheter
- Applicant
- Menlo Care, Inc.
Menlo Park, CA, US - Received
- August 9, 1994
- Decision date
- March 7, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K964447 | Picc Catheter/Midline CatheterLJS · Traditional | 04/16/1997SE |
| K951620 | Midmark Midline CatheterFOZ · Traditional | 04/04/1996SE |
| K945521 | Centermark(R) Picc Insertion Tray Landmark(R) Midline Catheter Prep TrayFOZ · Traditional | 04/06/1995SE |
| K950737 | Landmark Midline CatheterFOZ · Traditional | 03/29/1995SE |
| K944968 | Landmark Midline CatheterFOZ · Traditional | 03/29/1995SE |
| K943143 | Biliary StentFGE · Traditional | 02/28/1995SE |
| K930048 | Safe-Picc CatheterFOZ · Traditional | 05/12/1994SE |
| K933941 | Menlo Care Urinary Diversion StentFAD · Traditional | 03/31/1994SE |
| K940127 | Centermark Securing WingsKMK · Traditional | 02/09/1994SE |
| K923394 | Menlo Care Aquastent SetFAD · Traditional | 11/16/1993SE |
Questions and answers
When was Percutaneous Grainage Catheter cleared by the FDA?
Percutaneous Grainage Catheter (K943893) received a 510(k) decision of Substantially Equivalent on March 7, 1995, 210 days after the submission was received.
What is the product code of K943893?
The FDA product code is LJE – Catheter, Nephrostomy, a Unclassified device.