Pulse*Spray Infusion System
FDA 510(k) K951602 · Angiodynamics, Div. E-Z-Em, Inc.
510(k) numberK951602
Submission
- Device name
- Pulse*Spray Infusion System
- Applicant
- Angiodynamics, Div. E-Z-Em, Inc.
Queensbury, NY, US - Received
- March 14, 1995
- Decision date
- June 14, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KRA – Catheter, Continuous Flush
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1210
- Specialty
- Cardiovascular
Other 510(k)s with product code KRA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254051 | Extroducer Infusion Catheter SystemKRA · Traditional | SmartWise Sweden AB | 09/11/2026SE |
| K261610 | Verge MicrocatheterKRA · Special | Instylla, Inc. | 06/11/2026SE |
| K260771 | TruSelect 2.6 MicrocatheterKRA · Special | Boston Scientific Corporation | 05/15/2026SE |
| K250794 | InVera Infusion DeviceKRA · Traditional | Invera Medical | 03/12/2026SE |
| K243534 | Micro CatheterKRA · Traditional | Suzhou Zenith Vascular SciTech Limited | 07/30/2025SE |
| K231821 | XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S…KRA · Traditional | Transit Scientific, LLC | 11/29/2023SE |
| K231279 | Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mmKRA · Traditional | Ablative Solutions, Inc. | 07/05/2023SE |
| K231148 | ScleroSafe 150 mm, ScleroSafe 350 mmKRA · Traditional | Vvt Medical , Ltd. | 06/20/2023SE |
| K230957 | TriSalus TriNav® LV Infusion SystemKRA · Traditional | Trisalus Life Sciences | 05/02/2023SE |
| K223139 | Wallaby 017 Micro CatheterKRA · Traditional | Wallaby Medical | 04/25/2023SE |
More from Wallaby Medical
| 510(k) | Device | Decision |
|---|---|---|
| K961763 | Pulse*Spray Infusion SystemQEY · Traditional | 07/17/1996SE |
| K951509 | Pulse*Spray Infusion SystemQEY · Traditional | 06/16/1995SE |
| K950907 | Pulse*Spray Infusion SystemQEY · Traditional | 05/17/1995SE |
| K933846 | Angiography Syringe KitsDXT · Traditional | 12/13/1994SE |
| K923120 | Microguide Lesion Marking SystemGDF · Traditional | 09/01/1992SE |
Questions and answers
When was Pulse*Spray Infusion System cleared by the FDA?
Pulse*Spray Infusion System (K951602) received a 510(k) decision of Substantially Equivalent on June 14, 1995, 92 days after the submission was received.
What is the product code of K951602?
The FDA product code is KRA – Catheter, Continuous Flush, a Class II (moderate risk) device regulated under 21 CFR 870.1210.