Pediatric Europhylic Foley Catheter
FDA 510(k) K954752 · Regulatory & Marketing Services, Inc.
510(k) numberK954752
Submission
- Device name
- Pediatric Europhylic Foley Catheter
- Applicant
- Regulatory & Marketing Services, Inc.
Palm Harbor, FL, US - Received
- October 16, 1995
- Decision date
- October 30, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EZL – Catheter, Retention Type, Balloon
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code EZL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260756 | TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)EZL · Traditional | Sentinel Medical Technologies, | 09/04/2026SE |
| K262056 | Rusch Latex Gold Foley CatheterEZL · Traditional | Teleflex Medical Sdn. Bhd. | 08/05/2026SE |
| K252537 | Rusch SoftSimplastic Foley CathetersEZL · Traditional | Teleflex Medical Sdn. Bhd. | 01/20/2026SE |
| K243011 | Silicone Urethral Catheter (Silicone Urethral Catheter)EZL · Traditional | Guangdong Ecan Medical Co., Ltd. | 06/16/2025SE |
| K241424 | InnoCare Specialty Foley CatheterEZL · Traditional | Innocare Urologics, LLC | 09/18/2024SE |
| K232469 | Rüsch Latex Gold Foley CatheterEZL · Traditional | Teleflexmedical, Inc. | 08/01/2024SE |
| K240057 | TraumaGuard Intra-abdominal Pressure Sensing SystemEZL · Traditional | Sentinel Medical Technologies, LLC | 04/17/2024SE |
| K233411 | Folysil Silicone CatheterEZL · Traditional | Coloplast Corp. | 04/15/2024SE |
| K233013 | 2-Way 100% Silicone Cleartract CatheterEZL · Traditional | Silq Technologies Corporation | 01/23/2024SE |
| K212077 | Teleflex Rusch SoftSimplastic Foley CathetersEZL · Traditional | Teleflexmedical, Inc. | 07/27/2023SE |
More from Teleflexmedical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K944673 | Mri's All Silicone Foley Catheter Temperature ProbeEZL · Traditional | 04/10/1996SE |
| K941342 | Pain DocGZB · Traditional | 10/13/1995SE |
| K941543 | Dial Medical KitKOC · Traditional | 02/16/1995SESK |
| K944384 | Orion's Urethral Catheterization Kit Without BagFGM · Traditional | 02/15/1995SE |
| K944379 | Orion's Foley Catheterization Kit with Catheter and BagFGM · Traditional | 02/15/1995SE |
| K944378 | Orion's Urethral Catheterization Kit with Catheter and BagFGM · Traditional | 02/15/1995SE |
| K945874 | Euromedical Poly Tracheotomy TubeJOH · Traditional | 12/27/1994SE |
| K944383 | Orion Red Urethral CatheterEZD · Traditional | 12/06/1994SE |
| K944382 | Orion All Silicone Foley CatheterEZL · Traditional | 12/06/1994SE |
| K944377 | Orion's Urinary Drainage SetKNX · Traditional | 12/06/1994SE |
Questions and answers
When was Pediatric Europhylic Foley Catheter cleared by the FDA?
Pediatric Europhylic Foley Catheter (K954752) received a 510(k) decision of Substantially Equivalent on October 30, 1995, 14 days after the submission was received.
What is the product code of K954752?
The FDA product code is EZL – Catheter, Retention Type, Balloon, a Class II (moderate risk) device regulated under 21 CFR 876.5130.