Instylla Microcatheter
Instylla Microcatheter provides access to small vessels and selective peripheral anatomy for diagnostic and interventional procedures. It tracks over a steerable guidewire through an outer…
Instylla Microcatheter provides access to small vessels and selective peripheral anatomy for diagnostic and interventional procedures. It tracks over a steerable guidewire through an outer guiding catheter and delivers diagnostic, embolic or therapeutic materials.
The single-lumen catheter has a 1.7 Fr outer diameter, 0.016-inch inner diameter and distal radiopaque marker. It accepts guidewires no larger than 0.014 inch and comes in 122, 142 and 162 cm usable lengths.
Connectors and Materials
A proximal Luer hub accepts accessories, while strain relief supports securement in a Tuohy-Borst adapter. The system includes adapters and a duckbill check valve. Catheter materials include Pebax, a PTFE inner layer and a platinum-iridium marker.
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Wallaby Medical Technologies Co., Inc. | Shanghai | Shanghai | Contract manufacturer | 5 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Suzhou Zenith Vascular Scitech Limited | Suzhou | Jiangsu | Manufacturer | 6 |
| Suzhou Hengrui Hongyuan Medical Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
| Vascupatent Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 1 |
Record
| Listed by | Instylla, Inc., United States |
|---|---|
| FDA product code | KRA |
| Device type | Catheter, Continuous Flush |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1210 |
| Establishment | Manufacturer |
| 510(k) | K200744 |
| Record published | 2020-11-20 |
| Record revised | 2021-09-08 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 122 to 162 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| INS90-2001-005 | Diameter 1.7 Fr | In distribution |
| INS90-2001-004 | Diameter 1.7 Fr | In distribution |
| INS90-2001-006 | Diameter 1.7 Fr | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fountain® | Merit Medical Systems, Inc. | 154 |
| PulseSpray | AngioDynamics, Inc. | 149 |
| Merit Maestro® | Merit Medical Systems, Inc. | 143 |
| Phenom™ Catheter | Cathera, Inc. | 103 |
| UniFuse | AngioDynamics, Inc. | 84 |
| CXI | Cook Incorporated | 48 |
| Uni-Fuse+ | AngioDynamics, Inc. | 32 |
| Prowler | Medos International Sàrl | 27 |
| Truwave, Vamp | Edwards Lifesciences Technology Sarl | 26 |
| ICU Medical | ICU Medical, Inc | 21 |
| Cantata | Cook Incorporated | 20 |
| Truwave, Vamp Plus | Edwards Lifesciences Technology Sarl | 19 |
Showing 12 of 149. All products under Catheter, Continuous Flush
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261610 | 2026-06-11 |
| K210808 | 2021-04-15 |
| K200744 | 2020-04-21 |
| K191731 | 2019-08-13 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.