Instylla Microcatheter
FDA 510(k) K191731 · Instylla, Inc.
510(k) numberK191731
Submission
- Device name
- Instylla Microcatheter
- Applicant
- Instylla, Inc.
Waltham, MA, US - Received
- June 28, 2019
- Decision date
- August 13, 2019
- 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
| 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 |
|---|---|---|
| K261610 | Verge MicrocatheterKRA · Special | 06/11/2026SE |
| K253769 | Instylla Delivery KitFMF · Special | 12/22/2025SE |
| K253677 | Tembo Embolic SystemKRD · Special | 12/15/2025SE |
| K240873 | TEMBO Embolic SystemKRD · Traditional | 12/16/2024SE |
| K213632 | Instylla Delivery KitFMF · Special | 02/10/2022SE |
| K210808 | Instylla Microcatheter 1.2KRA · Special | 04/15/2021SE |
| K202544 | Instylla Delivery KitFMF · Special | 01/07/2021SE |
| K200744 | Instylla MicrocatheterKRA · Special | 04/21/2020SE |
| K191659 | Instylla Delivery KitFMF · Traditional | 10/10/2019SE |
Questions and answers
When was Instylla Microcatheter cleared by the FDA?
Instylla Microcatheter (K191731) received a 510(k) decision of Substantially Equivalent on August 13, 2019, 46 days after the submission was received.
What is the product code of K191731?
The FDA product code is KRA – Catheter, Continuous Flush, a Class II (moderate risk) device regulated under 21 CFR 870.1210.