Shockwave IVL System With the Shockwave M5+ Peripheral IVL Catheter
The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within…
The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator).
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
Record
| Listed by | Shockwave Medical, Inc., United States |
|---|---|
| FDA product code | OEZ |
| Device type | Cardiovascular Procedure Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1200 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2021-05-11 |
| Record revised | 2025-12-25 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep dry and keep away from heat |
| Sizes | Balloon diameter 4.5 to 8 mm; balloon nominal (inflation) pressure 6 Atmosphere; balloon rated burst pressure 10 Atmosphere; balloon length 60 mm; introducer sheath compatibility 6 Fr; balloon proximal outer diameter (od) 0.078 in; guidewire diameter 0.014 in; catheter working length 135 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M5PIVL6060 | Catheter Working Length 135 cm | In distribution |
| M5PIVL8060 | Catheter Working Length 135 cm | In distribution |
| M5PIVL5060 | Catheter Working Length 135 cm | In distribution |
| M5PIVL7060 | Catheter Working Length 135 cm | In distribution |
| M5PIVL6560 | Catheter Working Length 135 cm | In distribution |
| M5PIVL5560 | Catheter Length 135 cm | In distribution |
| M5PIVL4560 | Catheter Working Length 135 cm | In distribution |
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| Namic | Medline Industries, Inc. | 2,718 |
| Merit Medical® | Merit Medical Systems, Inc. | 2,399 |
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| ACS | American Contract Systems, Inc. | 1,540 |
| Medline | Medline Industries, Inc. | 428 |
| Stradis Healthcare | Stradis Healthcare | 263 |
| Regard™ | ROi CPS LLC | 192 |
| Stradis | Stradis Healthcare | 108 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 72 |
Showing 12 of 52. All products under Cardiovascular Procedure Kit
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.