CVD Bullett Hi-Flo Infusion Catheter
FDA 510(k) K951503 · Cardiovascular Dynamics, Inc.
510(k) numberK951503
Submission
- Device name
- CVD Bullett Hi-Flo Infusion Catheter
- Applicant
- Cardiovascular Dynamics, Inc.
Irvine, CA, US - Received
- March 28, 1995
- Decision date
- May 4, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K973713 | 22 Gauge P.D. Access Vascular Access Device (Catheter/Needle Assembly), 24 Gauge P.D.…ITX · Traditional | 01/23/1998SE |
| K971577 | Focus-Pv Balloon Dilatation CatheterLIT · Traditional | 06/18/1997SE |
| K963989 | P.D. Access (Percutaneous Doppler) Vascular Access DeviceITX · Traditional | 04/24/1997SE |
| K963688 | Focus PV Balloon Dilatation CatheterLIT · Traditional | 03/28/1997SE |
| K945693 | CVD Periflow(Tm) (Small Vessel) Balloon Dilatation CatheterLIT · Traditional | 08/17/1995SE |
| K952064 | Focus Balloon Dilatation CatheterLIT · Traditional | 06/21/1995SE |
| K951502 | CVD Bullet Infusion CatyheterKRA · Traditional | 05/10/1995SE |
| K945465 | CVD Small Vessel Balloon Dilatation CatheterLIT · Traditional | 12/20/1994SE |
| K944016 | Focus Balloon Dilatation CatheterLIT · Traditional | 12/20/1994SE |
| K943023 | CVD Bullett Peripheral Infusion CatheterFOZ · Traditional | 09/30/1994SE |
Questions and answers
When was CVD Bullett Hi-Flo Infusion Catheter cleared by the FDA?
CVD Bullett Hi-Flo Infusion Catheter (K951503) received a 510(k) decision of Substantially Equivalent on May 4, 1995, 37 days after the submission was received.
What is the product code of K951503?
The FDA product code is KRA – Catheter, Continuous Flush, a Class II (moderate risk) device regulated under 21 CFR 870.1210.