Gladiator™ Elite
102 catalogue numbers from H74939207090270, listed by Boston Scientific Corporation, United States, under Catheter, Angioplasty, Peripheral, Transluminal. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
102catalogue numbers in this listing
52510(k) clearances naming this product code
7recalls on this code
Who Else Makes It
Concentrated in Jiangsu (3), Guangdong (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| OrbusNeich Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Complaint-file establishment | 5 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
| Brosmed Medical Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Kossel Medtech (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 4 |
| DK Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
Record
| Listed by | Boston Scientific Corporation, United States |
|---|---|
| FDA product code | LIT |
| Device type | Catheter, Angioplasty, Peripheral, Transluminal |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2019-08-09 (version 3) |
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 |
|---|---|---|
| H74939207090270 | 20 mm Effective Length | In distribution |
| H74939207040670 | 4.0 mm Diameter | In distribution |
| H74939207030870 | 3.0 mm Diameter | In distribution |
| H74939207120240 | 20 mm Effective Length | In distribution |
| H74939207031070 | 3.0 mm Diameter | In distribution |
| H74939207060370 | 75 cm Length | In distribution |
| H74939207100840 | 10.0 mm Diameter | In distribution |
| H74939207060870 | 80 mm Effective Length | In distribution |
| H74939207030470 | 75 cm Length | In distribution |
| H74939207060470 | 6.0 mm Diameter | In distribution |
| H74939207080240 | 40 cm Length | In distribution |
| H74939207070640 | 60 mm Effective Length | In distribution |
| H74939207040840 | 80 mm Effective Length | In distribution |
| H74939207070870 | 80 mm Effective Length | In distribution |
| H74939207100370 | 30 mm Effective Length | In distribution |
| H74939207070840 | 40 cm Length | In distribution |
| H74939207061040 | 6.0 mm Diameter | In distribution |
| H74939207030370 | 75 cm Length | In distribution |
| H74939207030670 | 3.0 mm Diameter | In distribution |
| H74939207050840 | 40 cm Length | In distribution |
| H74939207090640 | 9.0 mm Diameter | In distribution |
| H74939207050470 | 40 mm Effective Length | In distribution |
| H74939207090840 | 9.0 mm Diameter | In distribution |
| H74939207040270 | 75 cm Length | In distribution |
| H74939207050440 | 5.0 mm Diameter | In distribution |
| H74939207120670 | 75 cm Length | In distribution |
| H74939207090470 | 9.0 mm Diameter | In distribution |
| H74939207050370 | 5.0 mm Diameter | In distribution |
| H74939207060670 | 60 mm Effective Length | In distribution |
| H74939207080340 | 30 mm Effective Length | In distribution |
| H74939207051040 | 5.0 mm Diameter | In distribution |
| H74939207070670 | 75 cm Length | In distribution |
| H74939207040240 | 20 mm Effective Length | In distribution |
| H74939207060240 | 6.0 mm Diameter | In distribution |
| H74939207030270 | 20 mm Effective Length | In distribution |
| H74939207041070 | 4.0 mm Diameter | In distribution |
| H74939207070440 | 7.0 mm Diameter | In distribution |
| H74939207070340 | 7.0 mm Diameter | In distribution |
| H74939207041040 | 4.0 mm Diameter | In distribution |
| H74939207070470 | 40 mm Effective Length | In distribution |
| H74939207030840 | 40 cm Length | In distribution |
| H74939207100340 | 30 mm Effective Length | In distribution |
| H74939207071070 | 75 cm Length | In distribution |
| H74939207090370 | 9.0 mm Diameter | In distribution |
| H74939207050670 | 5.0 mm Diameter | In distribution |
| H74939207090240 | 40 cm Length | In distribution |
| H74939207100870 | 10.0 mm Diameter | In distribution |
| H74939207090670 | 9.0 mm Diameter | In distribution |
| H74939207050240 | 5.0 mm Diameter | In distribution |
| H74939207060640 | 6.0 mm Diameter | In distribution |
| H74939207050340 | 5.0 mm Diameter | In distribution |
| H74939207040340 | 40 cm Length | In distribution |
| H74939207031040 | 100 mm Effective Length | In distribution |
| H74939207040440 | 4.0 mm Diameter | In distribution |
| H74939207090870 | 75 cm Length | In distribution |
| H74939207040640 | 4.0 mm Diameter | In distribution |
| H74939207060440 | 40 mm Effective Length | In distribution |
| H74939207080670 | 8.0 mm Diameter | In distribution |
| H74939207100470 | 75 cm Length | In distribution |
| H74939207071040 | 7.0 mm Diameter | In distribution |
| H74939207080870 | 75 cm Length | In distribution |
| H74939207120870 | 12.0 mm Diameter | In distribution |
| H74939207081040 | 40 cm Length | In distribution |
| H74939207090440 | 40 cm Length | In distribution |
| H74939207100670 | 60 mm Effective Length | In distribution |
| H74939207050640 | 5.0 mm Diameter | In distribution |
| H74939207100240 | 10.0 mm Diameter | In distribution |
| H74939207120470 | 12.0 mm Diameter | In distribution |
| H74939207120640 | 40 cm Length | In distribution |
| H74939207080470 | 8.0 mm Diameter | In distribution |
| H74939207120270 | 12.0 mm Diameter | In distribution |
| H74939207070270 | 75 cm Length | In distribution |
| H74939207051070 | 75 cm Length | In distribution |
| H74939207080370 | 75 cm Length | In distribution |
| H74939207030440 | 40 mm Effective Length | In distribution |
| H74939207081070 | 100 mm Effective Length | In distribution |
| H74939207100270 | 20 mm Effective Length | In distribution |
| H74939207120370 | 30 mm Effective Length | In distribution |
| H74939207120340 | 30 mm Effective Length | In distribution |
| H74939207080440 | 8.0 mm Diameter | In distribution |
| H74939207100640 | 60 mm Effective Length | In distribution |
| H74939207030340 | 30 mm Effective Length | In distribution |
| H74939207050270 | 5.0 mm Diameter | In distribution |
| H74939207080270 | 75 cm Length | In distribution |
| H74939207030240 | 3.0 mm Diameter | In distribution |
| H74939207070370 | 75 cm Length | In distribution |
| H74939207080640 | 8.0 mm Diameter | In distribution |
| H74939207070240 | 20 mm Effective Length | In distribution |
| H74939207040870 | 4.0 mm Diameter | In distribution |
| H74939207100440 | 10.0 mm Diameter | In distribution |
| H74939207030640 | 40 cm Length | In distribution |
| H74939207060340 | 6.0 mm Diameter | In distribution |
| H74939207120840 | 12.0 mm Diameter | In distribution |
| H74939207061070 | 6.0 mm Diameter | In distribution |
| H74939207120440 | 40 mm Effective Length | In distribution |
| H74939207040370 | 75 cm Length | In distribution |
| H74939207060270 | 6.0 mm Diameter | In distribution |
| H74939207060840 | 40 cm Length | In distribution |
| H74939207040470 | 40 mm Effective Length | In distribution |
| H74939207050870 | 5.0 mm Diameter | In distribution |
| H74939207090340 | 40 cm Length | In distribution |
| H74939207080840 | 80 mm Effective Length | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Parafleet SC 018 PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 1,460 |
| Jade Plus PTA Balloon Dilatation Catheter / Jade Plus 18 OTW | OrbusNeich Medical (Shenzhen) Co., Ltd. | 832 |
| Jade PTA Balloon Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 667 |
| Parafleet SC 014 PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 572 |
| Minerva PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 504 |
| Advocate | Arravasc, Ltd. | 441 |
| Ultraverse® 035 PTA Dilatation Catheter | Bard Peripheral Vascular, Inc. | 361 |
| Polux PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 359 |
| Advance | Cook Incorporated | 355 |
| Pacific™ Plus | Medtronic, Inc. | 347 |
| EverCross™ | ev3, Inc. | 316 |
| Achilles NC PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 297 |
Showing 12 of 167. All products under Catheter, Angioplasty, Peripheral, Transluminal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241683 | 2024-07-10 |
| K201170 | 2020-09-15 |
| K162350 | 2016-11-04 |
| K143193 | 2015-07-24 |
| K150303 | 2015-06-15 |
| K141150 | 2014-09-25 |
| K141521 | 2014-08-21 |
| K141112 | 2014-07-16 |
| K132810 | 2014-02-28 |
| K132430 | 2013-10-17 |
| K113681 | 2012-01-11 |
| K112697 | 2011-11-30 |
| K111295 | 2011-05-31 |
| K103751 | 2011-03-22 |
| K093636 | 2009-12-23 |
| K093720 | 2009-12-23 |
| K092455 | 2009-09-04 |
| K080982 | 2008-07-14 |
| K071309 | 2007-07-13 |
| K071042 | 2007-06-13 |
| K060959 | 2006-04-12 |
| K060960 | 2006-04-12 |
| K052038 | 2005-08-16 |
| K001134 | 2000-08-31 |
| K000798 | 2000-06-08 |
| K992320 | 2000-05-18 |
| K000570 | 2000-04-13 |
| K993305 | 2000-04-10 |
| K972744 | 1997-12-11 |
| K972357 | 1997-11-19 |
| K970379 | 1997-05-01 |
| K960501 | 1996-04-09 |
| K953569 | 1995-12-20 |
| K952063 | 1995-11-14 |
| K953602 | 1995-10-18 |
| K934191 | 1993-12-09 |
| K924320 | 1993-11-10 |
| K923611 | 1993-11-04 |
| K921254 | 1992-12-03 |
| K922610 | 1992-11-18 |
| K924276 | 1992-11-10 |
| K924047 | 1992-11-02 |
| K920547 | 1992-05-06 |
| K913391 | 1991-11-05 |
| K913689 | 1991-10-16 |
| K910995 | 1991-04-09 |
| K911203 | 1991-04-09 |
| K896520 | 1991-03-25 |
| K900094 | 1990-10-31 |
| K897106 | 1990-10-16 |
| K897124 | 1990-07-17 |
| K901018 | 1990-05-30 |
Recalls
5 of these are Class II. 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 |
|---|---|---|---|---|---|
| 2025-12-03 | Class II | Process change control | Boston Scientific is initiating the removal of certain batches of Coyote” Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to the potential for inflation/deflation difficulty during use | 21 units | |
| 2014-02-04 | Class II | Device Design | Boston Scientific is initiating this Recall Removal of one lot of the Coyote” OVER-THE-WIRE PTA Balloon Dilatation Catheter and one lot of the Coyote” MONORAIL” PTA Balloon Dilatation Catheter. Boston Scientific has become aware that the ba | 35 for both products. | 2014-08-04 |
| 2014-02-04 | Class II | Device Design | Boston Scientific is initiating this Recall Removal of one lot of the Coyote” OVER-THE-WIRE PTA Balloon Dilatation Catheter and one lot of the Coyote” MONORAIL” PTA Balloon Dilatation Catheter. Boston Scientific has become aware that the ba | 35 for both products | 2014-08-04 |
| 2013-07-31 | Class II | Process change control | Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Devices and Flextome Cutting Balloon (Monorail and Over-the-Wire) Microsurgi | 340 | 2015-01-27 |
| 2013-07-31 | Class II | Process change control | Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Devices and Flextome Cutting Balloon (Monorail and Over-the-Wire) Microsurgi | 1,331 | 2015-01-27 |
| 2010-02-18 | Not classified | Packaging | Boston Scientific Corporation is conducting a Medical Device Recall Removal of specific lots/batches of the Blue Max and Ultrathin Diamond Balloon Dilatation Catheters. Boston Scientific has determined that, the sterile barrier in the cathe | 73 | 2011-12-10 |
| 2005-12-07 | Not classified | Other | The distal shaft of the catheter may separate during withdrawal of the device from the patient. If the shaft separates, the surgical procedure may be prolonged or require more in-depth surgery to physically remove the broken-off shaft from | individual qty in US:376, Worldwide distribution pending. | 2007-08-10 |
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.