In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath
FDA 510(k) K201165 · Coloplast Corp.
510(k) numberK201165
Submission
- Device name
- In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath
- Applicant
- Coloplast Corp.
Plymouth, MN, US - Received
- May 1, 2020
- Decision date
- December 17, 2020
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| 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 |
| K171601 | Ultraxx Nephrostomy Balloon CatheterLJE · Traditional | Cook Incorporated | 02/23/2018SE |
More from Cook Incorporated
| 510(k) | Device | Decision |
|---|---|---|
| K252140 | Heylo SystemEXB · Traditional | 10/06/2025SE |
| K251116 | Luja CoudéEZD · Traditional | 06/27/2025SE |
| K250270 | Luja SetEZD · Special | 04/17/2025SE |
| K242049 | SureCath SetEZD · Traditional | 11/26/2024SE |
| K241210 | Luja CoudeEZD · Traditional | 11/21/2024SE |
| K242173 | Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10…FED · Traditional | 11/12/2024SE |
| K242473 | Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551)…PAH · Traditional | 10/18/2024SE |
| K241028 | Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)EZD · Traditional | 07/26/2024SE |
| K233411 | Folysil Silicone CatheterEZL · Traditional | 04/15/2024SE |
| K231953 | Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x…FRO · Traditional | 03/22/2024SE |
Questions and answers
When was In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath cleared by the FDA?
In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath (K201165) received a 510(k) decision of Unknown on December 17, 2020, 230 days after the submission was received.
What is the product code of K201165?
The FDA product code is LJE – Catheter, Nephrostomy, a Unclassified device.