Instylla Microcatheter 1.2
Instylla Microcatheter 1.2 delivers diagnostic, embolic or therapeutic materials into small peripheral vessels. It advances through a guiding catheter and tracks over a steerable guidewire…
Instylla Microcatheter 1.2 delivers diagnostic, embolic or therapeutic materials into small peripheral vessels. It advances through a guiding catheter and tracks over a steerable guidewire to reach the selected site.
The single-lumen catheter has a 1.2 Fr outer diameter and a 0.012-inch inner diameter. A distal radiopaque marker supports fluoroscopic positioning, and a proximal luer hub connects delivery accessories.
Positioning and Adapters
The proximal strain-relief section can be secured inside a Tuohy-Borst sideport adapter to maintain position within the guiding catheter. Extension adapters and a duckbill check valve are also included. The catheter accepts guidewires smaller than 0.010 inches and is offered in 122, 142 and 162 cm usable lengths.
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) | K210808 |
| Record published | 2021-09-07 |
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 |
|---|---|---|
| INS90-2001-007 | Length 122 cm | In distribution |
| INS90-2001-009 | Length 162 cm | In distribution |
| INS90-2001-008 | Length 142 cm | 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.