Amsure PVC Intermittent Catheter
FDA 510(k) K091306 · Amsino International, Inc.
510(k) numberK091306
Submission
- Device name
- Amsure PVC Intermittent Catheter
- Applicant
- Amsino International, Inc.
Pomona, CA, US - Received
- May 4, 2009
- Decision date
- August 21, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EZD – Catheter, Straight
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code EZD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260737 | Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure…EZD · Traditional | Convatec | 08/05/2026SE |
| K261658 | LoFric Origo Pro CoudéEZD · Special | Wellspect AB | 07/17/2026SE |
| K262045 | Luja SoftEZD · Special | Coloplast A.S. | 07/07/2026SE |
| K260394 | Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)EZD · Traditional | Hangzhou Jimushi Meditech Co., Ltd. | 06/24/2026SE |
| K253295 | Coude Sleeved IC; Coude Plus Sleeved ICEZD · Traditional | Hollister Incorporated | 05/18/2026SE |
| K260999 | LoFric Elle ProEZD · Special | Wellspect AB | 04/24/2026SE |
| K252943 | GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for WomenEZD · Traditional | Convatec Limited | 04/01/2026SE |
| K260502 | Liv Pre-lubricated Intermittent CatheterEZD · Traditional | HR Healthcare | 03/12/2026SE |
| K251274 | EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic…EZD · Traditional | HR Healthcare | 01/29/2026SESK |
| K251178 | Ready to use Nelaton CatheterEZD · Traditional | Jamjoom Fullcare Corporation | 01/02/2026SE |
More from Jamjoom Fullcare Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K252543 | AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072…FPA · Traditional | 05/04/2026SE |
| K220230 | AMSure Enteral Feeding PumpLZH · Traditional | 11/10/2022SE |
| K220267 | AMSafe NeuFlo Needleless ConnectorFPA · Traditional | 10/07/2022SE |
| K213522 | AMSafe Pre-Filled Normal Saline Flush SyringeNGT · Traditional | 03/22/2022SE |
| K200051 | PUGGLE Enteral Feeding Pump and Feeding SetLZH · Traditional | 09/25/2020SE |
| K183473 | AMSafe(R) Pre-Filled Normal Saline Flush SyringeNGT · Traditional | 07/12/2019SE |
| K181445 | AMSure Hydrophilic Intermittent CatheterEZD · Traditional | 10/01/2018SE |
| K181423 | AMSure Sterile Water, and Sterile Normal Saline for Wound FlushFRO · Traditional | 09/07/2018SE |
| K173665 | AMSafe Sure-Lok Needle-Free ConnectorFPA · Traditional | 09/05/2018SE |
| K181814 | AMSure Pre-filled Syringe for Balloon Inflation with Sterile WaterEZL · Traditional | 09/04/2018SE |
Questions and answers
When was Amsure PVC Intermittent Catheter cleared by the FDA?
Amsure PVC Intermittent Catheter (K091306) received a 510(k) decision of Substantially Equivalent on August 21, 2009, 109 days after the submission was received.
What is the product code of K091306?
The FDA product code is EZD – Catheter, Straight, a Class II (moderate risk) device regulated under 21 CFR 876.5130.