1 Mass Transit Infusion Catheter, 1 Various
FDA 510(k) K983003 · Cordis Neurovascular, Inc.
510(k) numberK983003
Submission
- Device name
- 1 Mass Transit Infusion Catheter, 1 Various
- Applicant
- Cordis Neurovascular, Inc.
Miami Lake, FL, US - Received
- August 28, 1998
- Decision date
- September 17, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
| 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 |
|---|---|---|
| K082324 | Trufill DCS SyringeHCG · Special | 09/12/2008SE |
| K080967 | Trufill DCS Orbit Detachable Coil and Trufill DCS Syringe or Trufill DCS Syringe II…HCG · Special | 05/02/2008SE |
| K071962 | Vascular Occlusion System (Trufill Pushable Coils and Trupush Coil Pusher)HCG · Special | 09/26/2007SE |
| K070279 | Modification to Hypertransit Infusion CatheterKRA · Special | 03/14/2007SE |
| K063254 | The Trufill DCS Detachable Coil System; the Trufill DCS Orbit Detachable Coil SystemHCG · Traditional | 12/07/2006SE |
| K053197 | Trufill DCS Orbit Detachable Coil System Line ExtensionHCG · Special | 12/15/2005SE |
| K043538 | Hypertransit Infusion CatheterKRA · Traditional | 04/18/2005SE |
| K032553 | Trufill DCS Orbit Detachable Coil and Trufill DCS Syringe, Also Known AS Trufill DCS…HCG · Special | 09/23/2003SE |
| K030963 | Trufill DCS Orbit Detachable Coil and Trufill DCS Syringe, Also Known AS the Trufill DCS…HCG · Traditional | 06/20/2003SE |
| K021591 | Prowler Select (10, 14, and Plus) Infusion Catheters with and Without Pre-Shaped TipsKRA · Special | 05/22/2002SE |
Questions and answers
When was 1 Mass Transit Infusion Catheter, 1 Various cleared by the FDA?
1 Mass Transit Infusion Catheter, 1 Various (K983003) received a 510(k) decision of Substantially Equivalent on September 17, 1998, 20 days after the submission was received.
What is the product code of K983003?
The FDA product code is KRA – Catheter, Continuous Flush, a Class II (moderate risk) device regulated under 21 CFR 870.1210.