Stealth
STEALTH Peripheral, Radial Access OAD, 1.75mm, 30mm, 180cm shaft, 120 krpm High Speed, 90 krpm Medium Speed, 60 krpm Low Speed
3manufacturers in China registered for this device type
20catalogue numbers in this listing
21510(k) clearances naming this product code
12recalls on this code
Who Else Makes It
All of them in Guangdong. 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| ATL Technology DG,Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Quasar Electronics Technology (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
| Dongguan King Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
Record
| Listed by | Cardiovascular Systems Incorporated, United States |
|---|---|
| FDA product code | MCW |
| Device type | Catheter, Peripheral, Atherectomy |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4875 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2019-09-10 |
| Record revised | 2025-12-15 (version 5) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DBE-150 | In distribution | |
| RAD-SC30-175 | Crown Diameter 1.75 mm | In distribution |
| DBE-200 | Intro Sheath 6 Fr | In distribution |
| PRD-SC30-150 | In distribution | |
| PRD-SC30-225 | 7 Fr Intro sheath | In distribution |
| DBE-150 | Intro Sheath 6 Fr | In distribution |
| RAD-SC30-175 | In distribution | |
| RAD-SC30-150 | Crown Diameter 1.5 mm | In distribution |
| RAD-SC30-150 | In distribution | |
| PRD-SC30-125 | Intro Sheath 6 Fr | In distribution |
| PRD-SC30-150 | Intro Sheath 6 Fr | In distribution |
| PRD-SC30-200 | In distribution | |
| PRD-SC30-MICRO | In distribution | |
| PRD-MAX-200 | Crown Diameter: 2.00 mm | In distribution |
| PRD-SC30-125 | In distribution | |
| RAD-SC30-125 | In distribution | |
| RAD-SC30-125 | Crown diameter 1.25mm | In distribution |
| PRD-SC30-200 | Intro Sheath 6 Fr | In distribution |
| DBE-200 | In distribution | |
| PRD-SC30-125S | Crown Type, Solid Micro | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Diamondback Peripheral | Cardiovascular Systems Incorporated | 44 |
| Turbo-Elite™ | Spectranetics Corp. | 24 |
| Zilient | Cardiovascular Systems Incorporated | 16 |
| TurboHawk | Covidien LP | 15 |
| HawkOne | Covidien LP | 14 |
| Turbo-Elite Laser Atherectomy Catheter | Spectranetics Corp. | 12 |
| SilverHawk | Covidien LP | 11 |
| Auryon Atherectomy Catheter | Eximo Medical Ltd | 10 |
| Revolution Peripheral Atherectomy System | Rex Medical | 8 |
| Peripheral RotaLink® Plus | Boston Scientific Corporation | 8 |
| SilverHawkTM | Covidien LP | 8 |
| Peripheral Rotapro™ | Boston Scientific Corporation | 8 |
Showing 12 of 102. All products under Catheter, Peripheral, Atherectomy
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K220109 | 2022-03-01 |
| K210586 | 2021-09-14 |
| K203008 | 2020-11-19 |
| K190634 | 2019-07-02 |
| K182397 | 2018-12-13 |
| K180416 | 2018-04-17 |
| K170792 | 2017-06-09 |
| K152694 | 2015-10-21 |
| K150732 | 2015-04-13 |
| K133999 | 2014-02-28 |
| K133399 | 2013-11-22 |
| K122987 | 2012-10-25 |
| K111388 | 2011-07-26 |
| K110389 | 2011-03-11 |
| K090521 | 2009-03-20 |
| K082981 | 2008-10-31 |
| K072748 | 2007-11-09 |
| K072800 | 2007-10-25 |
| K071427 | 2007-08-30 |
| K071350 | 2007-08-22 |
| K041630 | 2005-01-31 |
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2021-07-21 | Class II | Process control | There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged s 1.25mm Micro Crown OADs and vice versa. | 8 units | 2026-03-18 |
| 2021-07-21 | Class II | Process control | There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged s 1.25mm Micro Crown OADs and vice versa. | 8 units | 2026-03-18 |
| 2017-09-14 | Class II | Labeling mix-ups | Cardiovascular Systems, Inc. (CSI) is removing the products because it was identified that the labeling for two lots of product s were potentially inadvertently switched during production. | 8 | 2019-11-04 |
| 2017-09-14 | Class II | Labeling mix-ups | Cardiovascular Systems, Inc. (CSI) is removing the products because it was identified that the labeling for two lots of product s were potentially inadvertently switched during production. | 8 | 2019-11-04 |
| 2017-03-03 | Class II | Under Investigation by firm | Cardiovascular Systems, Inc. is recalling one lot of ViperWire Advance with Flextip, model VPR-GW-FT18 because it may contain a 0.014″ ViperWire Advance Flextip product instead of the 0.018″ ViperWire Advance with Flextip. | 186 devices | 2017-11-28 |
| 2017-02-09 | Class II | Process control | CSI is recalling three lots of VIPERWIRE ADVANCE WITH FLEXTIP PERIPHERAL ATHERECTOMY GUIDEWIRE. It was discovered that 0.018in ViperWire Advance with Flextip product was packaged as a 0.014in ViperWire Advance with Flextip. | 595 | 2017-07-27 |
| 2016-12-07 | Class II | Employee error | CSI discovered that a 1.50mm Solid Crown OAD was labeled as a 1.50mm Crown OED. | 8 units | 2017-03-23 |
| 2016-06-13 | Class II | Process control | The pouch label was missing the use by date (UBD) of 2018-04. | 190 units (38 – 5 pack shelf cartons) | 2016-08-16 |
| 2014-05-23 | Class I | Process control | CSI has initiated a recall on the Diamondback 360 Peripheral Orbital Atherectomy Device because it may contain a saline sheath that may experience cracking, fracture, and release particulate during use. | 48 | 2014-10-01 |
| 2012-06-18 | Class II | Employee error | CSI has initiated a recall on specific lot numbers of Stealth 360-degree Orbital Atherectomy devices which have the potential for an insufficient crown solder bond that may result in the crown becoming detached from the driveshaft. | 27 | 2012-07-19 |
| 2009-04-16 | Not classified | Incorrect or no expiration date | CSI is correcting (8) packages of Diamondback 360 due to a missing “Use By Date” on the device labeling. The labelling should have been a 12 month shelf life (2010-02) rather than no information for shelf life. The units affected by this c | 8 | 2011-12-10 |
| 2009-03-16 | Not classified | Incorrect or no expiration date | CSI is recalling 10 devices due to a mislabeling of the shelf life as shown on the device labeling. The labeling shown on the affected devices represents a 24 month shelf life rather than a 6 month shelf life that should have been indicate | 10 devices | 2012-04-20 |
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.