OrionTM
The FDA filing describes Orion as a 0.021-inch delivery microcatheter. Its construction includes a stainless-steel proximal hypotube and a distal Pebax shaft with Nitinol braid…
The FDA filing describes Orion as a 0.021-inch delivery microcatheter. Its construction includes a stainless-steel proximal hypotube and a distal Pebax shaft with Nitinol braid reinforcement.
The catheter is intended for controlled selective infusion of physician-specified therapeutic agents or contrast media into peripheral and neuro vasculature. The distal shaft includes radiopaque marker bands.
Listed Item
Microcatheter 105-5098-150 V02 Orion
Catheter Construction
The continuous PTFE liner provides a smooth inner diameter for low-friction stent delivery.
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 | Micro Therapeutics, Inc., United States |
|---|---|
| FDA product code | KRA |
| Device type | Catheter, Continuous Flush |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1210 |
| 510(k) | K113289 |
| Record published | 2016-07-25 |
| Record revised | 2025-08-13 (version 8) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2025-08-11 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 105-5098-150 | Withdrawn |
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 |
|---|---|
| K113289 | 2012-08-01 |
| K090870 | 2009-05-01 |
| K051990 | 2006-01-04 |
| K042187 | 2004-09-02 |
| K034036 | 2004-02-13 |
| K031992 | 2003-08-07 |
| K030688 | 2003-03-28 |
| K024122 | 2003-03-07 |
| K024118 | 2003-02-03 |
| K010004 | 2001-02-13 |
| K002723 | 2000-09-28 |
| K001966 | 2000-07-20 |
| K993672 | 2000-01-04 |
| K974473 | 1998-06-17 |
| K980104 | 1998-04-10 |
| K964868 | 1997-05-20 |
| K954020 | 1996-01-02 |
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.