Modification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe, Monojet Prefill Heprin Lock Flush Syringe
FDA 510(k) K032438 · Tyco Healthcare
510(k) numberK032438
Submission
- Device name
- Modification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe, Monojet Prefill Heprin Lock Flush Syringe
- Applicant
- Tyco Healthcare
Mansfield, MA, US - Received
- August 7, 2003
- Decision date
- June 30, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NGT – Saline, Vascular Access Flush
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5200
- Specialty
- General Hospital
Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.
Other 510(k)s with product code NGT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250884 | 0.9 % Sodium Chloride Injection, USP, BD PosiFlush SP SyringeNGT · Traditional | Becton, Dickinson and Company | 12/02/2025SE |
| K233623 | Praxiject SP 0.9% NaClNGT · Traditional | Medxl, Inc. | 02/27/2024SE |
| K231724 | Flush Syringe (Prefilled 0.9% normal saline solution)NGT · Traditional | Spm Medicare Pvt. , Ltd. | 11/09/2023SE |
| K231363 | Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)NGT · Traditional | Hantech Medical Device Co., Ltd. | 09/27/2023SE |
| K230756 | TK Pre-Filled Normal Saline Flush SyringeNGT · Traditional | Anhui Tiankang Medical Technology Co., Ltd. | 08/12/2023SE |
| K223584 | Pre-Filled Normal Saline Flush SyringeNGT · Traditional | Anhui Tianyang Pharmaceutical Co., Ltd. | 08/12/2023SE |
| K231161 | 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Saline Flush SyringeNGT · Traditional | Becton, Dickinson and Company | 07/21/2023SE |
| K231754 | Praxiject 0.9% NaClNGT · Special | Medxl, Inc. | 07/13/2023SE |
| K214080 | PentaflushNGT · Traditional | Pentaferte Italia S.R.L. | 07/20/2022SE |
| K213522 | AMSafe Pre-Filled Normal Saline Flush SyringeNGT · Traditional | Amsino International, Inc. | 03/22/2022SE |
More from Amsino International, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K071049 | Dover 100% Silicone Foley Catheter with Temperature SensorEZL · Traditional | 10/16/2007SE |
| K070685 | Kendall Antimicrobial Drain Dressing for OTC Use, Model 6662FRO · Traditional | 09/14/2007SE |
| K070653 | Kendall Kerlix Antimicrobial Super Sponge Dressing for OTC Use, Model 6662FRO · Traditional | 09/12/2007SE |
| K061492 | Monoject Magellan Insulin and Tuberculin Safety SyringeFMF · Traditional | 08/03/2006SE |
| K042709 | Dover Silver Temperature Sensing Foley CatheterEZL · Traditional | 01/18/2005SE |
| K040897 | Dover Rob-Nel CatheterKOD · Traditional | 07/20/2004SE |
| K040649 | Kendall SCD Express Kambia Thigh Length Tearaway SleeveJOW · Traditional | 07/15/2004SE |
| K041243 | Dover Red Rubber Robinson CatheterKOD · Traditional | 07/07/2004SE |
| K033453 | Kendall Ultec Pro Ag+ Hydrocolloid DressingFRO · Traditional | 04/29/2004SE |
| K032827 | Kendall Lifetrace Umbilical Blood Collection Kit, Code 56501KSR · Traditional | 12/08/2003SE |
Questions and answers
When was Modification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe, Monojet Prefill Heprin Lock Flush Syringe cleared by the FDA?
Modification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe, Monojet Prefill Heprin Lock Flush Syringe (K032438) received a 510(k) decision of Substantially Equivalent on June 30, 2004, 328 days after the submission was received.
What is the product code of K032438?
The FDA product code is NGT – Saline, Vascular Access Flush, a Class II (moderate risk) device regulated under 21 CFR 880.5200.