Prolong, Models PL50, PL100, PL150
FDA 510(k) K001129 · Life-Tech Intl., Inc.
510(k) numberK001129
Submission
- Device name
- Prolong, Models PL50, PL100, PL150
- Applicant
- Life-Tech Intl., Inc.
Stafford, TX, US - Received
- April 7, 2000
- Decision date
- July 6, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CAZ – Anesthesia Conduction Kit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5140
- Specialty
- Anesthesiology
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Other 510(k)s with product code CAZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K222341 | Arrow 0.2 Micron Flat Filter, GVSCAZ · Traditional | Arrow International, LLC | 02/13/2023SE |
| K210983 | BD Epilor SyringeCAZ · Traditional | Becton, Dickinson and Company | 05/19/2022SE |
| K201356 | Plastic LOR SyringeCAZ · Traditional | Jiangsu Caina Medical Co.,Ltd | 02/12/2021SE |
| K202699 | E-Cath STIM acc. TsuiCAZ · Special | PAJUNK GmbH Medizintechnologie | 12/29/2020SE |
| K190345 | VPCCAZ · Traditional | PAJUNK GmbH Medizintechnologie | 05/16/2019SE |
| K161075 | Arrow Epidural Catheter KitCAZ · Traditional | Teleflexmedical, Inc. | 10/04/2016SE |
| K153652 | ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/SetCAZ · Traditional | Teleflex, Inc. | 06/21/2016SE |
| K143581 | Arrow Epidural Catheter KitCAZ · Traditional | Teleflexmedical, Inc. | 06/26/2015SE |
| K122690 | Ultraquik Peripheral Nerve Block NeedleCAZ · Traditional | Arrow International, Inc. | 12/21/2012SE |
| K110053 | Correctinject Safety System, Catheter Connector, Filter, Infusion Adaptor, Syringe KitCAZ · Traditional | Smiths Medical Asd, Inc. | 09/14/2012SE |
More from Smiths Medical Asd, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K955031 | MaxistimKOI · Traditional | 12/10/1996SE |
| K954505 | Ez StimKOI · Traditional | 12/10/1996SE |
| K954315 | PVC Abdominal/Rectal Pressure CatheterFEN · Traditional | 11/30/1995SE |
| K954341 | Urodynamics Tubing and Infusion SetsFEN · Traditional | 10/17/1995SE |
| K953451 | Uropump Tube & Damping ChamgerFEN · Traditional | 10/05/1995SE |
| K953353 | Urovision JanusFEN · Traditional | 09/08/1995SE |
| K946108 | Ear-A-GatorKHH · Traditional | 06/13/1995SE |
| K913601 | MicrophorEGJ · Traditional | 07/15/1994SE |
| K940203 | Triple Lumen Urodynamic Catheter with Radiopaque MarkersFEN · Traditional | 03/30/1994SE |
| K931179 | Urolab SpectrumFAP · Traditional | 11/18/1993SE |
Questions and answers
When was Prolong, Models PL50, PL100, PL150 cleared by the FDA?
Prolong, Models PL50, PL100, PL150 (K001129) received a 510(k) decision of Substantially Equivalent on July 6, 2000, 90 days after the submission was received.
What is the product code of K001129?
The FDA product code is CAZ – Anesthesia Conduction Kit, a Class II (moderate risk) device regulated under 21 CFR 868.5140.