Primary Care Solutions Prefilled 10CC and Prefilled 30CC Inflation Syringes with Sterile Water Catalog Numbers 1010 and
FDA 510(k) K030813 · Primary Care Solutions, Inc.
510(k) numberK030813
Submission
- Device name
- Primary Care Solutions Prefilled 10CC and Prefilled 30CC Inflation Syringes with Sterile Water Catalog Numbers 1010 and
- Applicant
- Primary Care Solutions, Inc.
Zephyrhills, FL, US - Received
- March 14, 2003
- Decision date
- May 30, 2003
- 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 |
|---|---|---|
| K082330 | Primary Care Solutions, Inc., Sterile Water and Saline for IrrigationFRO · Traditional | 10/09/2008SE |
| K000266 | Primary Care Solutions Sterile SALINE-0.9% Sodium Chloride for Device IrrigationJOL · Traditional | 07/12/2001SE |
| K000265 | Primary Care Solutions Sterile Water Device IrrigationJOL · Traditional | 07/12/2001SE |
Questions and answers
When was Primary Care Solutions Prefilled 10CC and Prefilled 30CC Inflation Syringes with Sterile Water Catalog Numbers 1010 and cleared by the FDA?
Primary Care Solutions Prefilled 10CC and Prefilled 30CC Inflation Syringes with Sterile Water Catalog Numbers 1010 and (K030813) received a 510(k) decision of Substantially Equivalent on May 30, 2003, 77 days after the submission was received.
What is the product code of K030813?
The FDA product code is EZL – Catheter, Retention Type, Balloon, a Class II (moderate risk) device regulated under 21 CFR 876.5130.