Pacific Xtreme
Pacific Xtreme is an over-the-wire balloon catheter for dilating narrowing in the femoral, popliteal and infrapopliteal arteries. The catheter has a proximal hub, dual-lumen coaxial shaft…
Pacific Xtreme is an over-the-wire balloon catheter for dilating narrowing in the femoral, popliteal and infrapopliteal arteries. The catheter has a proximal hub, dual-lumen coaxial shaft and distal dilatation balloon.
A hydrophilic coating covers the catheter. It accepts guidewires up to 0.018 inch and is compatible with 4F or 5F introducer sheaths, depending on balloon diameter and length.
Listed Item
Cath PCU040300090 PCU US 04.00L300UL0900
Length Options
Usable catheter lengths are 90 and 130 cm. The described peripheral artery indications apply to balloon lengths of 150, 200, 250 and 300 mm. The device is designed for limited contact with circulating blood during the procedure.
5manufacturers in China registered for this device type
55catalogue numbers in this listing
3510(k) clearances naming this product code
1recall
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 | Medtronic, Inc., 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, Manufacturer, Exporter |
| 510(k) | K103464 |
| Record published | 2016-04-28 |
| Record revised | 2020-07-20 (version 4) |
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 |
| Storage | Special storage condition: Store at controlled room temperature, in a dry place. Do not expose to organic solvents (e.g. alcohol), ionizing radiati |
| Sizes | Outer diameter 4 to 7 mm; length 150 to 300 mm |
| Distribution end date | 2024-05-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PCU050150130 | Outer Diameter 5.0 mm | In distribution |
| PCU050150090 | Outer Diameter 5.0 mm | In distribution |
| PCU040250130 | Outer Diameter 4.0 mm | In distribution |
| PCU040250130 | Balloon Diameter 4 MM | In distribution |
| PCU050200090 | Balloon Length 200 MM | In distribution |
| PCU040150130 | Length 150.0 mm | In distribution |
| PCU060150090 | Balloon Diameter 6 MM | In distribution |
| PCU040200090 | Length 200.0 mm | In distribution |
| PCU060300130 | Balloon Length 300 MM | In distribution |
| PCU040250090 | Balloon Diameter 4 MM | In distribution |
| PCU060300090 | Balloon Diameter 6 MM | In distribution |
| PCU070150090 | Outer Diameter 7.0 mm | In distribution |
| PCU040150090 | Balloon Diameter 4 MM | In distribution |
| PCU060250130 | Balloon Length 250 MM | In distribution |
| PCU060300130 | Outer Diameter 6.0 mm | In distribution |
| PCU040150130 | Balloon Diameter 4 MM | In distribution |
| PCU060200090 | Balloon Length 200 MM | In distribution |
| PCU060150130 | Outer Diameter 6.0 mm | In distribution |
| PCU040300130 | Length 300.0 mm | In distribution |
| PCU040300130 | Balloon Length 300 MM | In distribution |
| PCU070200090 | Length 200.0 mm | In distribution |
| PCU070150130 | Outer Diameter 7.0 mm | In distribution |
| PCU070200130 | Balloon Diameter 7 MM | In distribution |
| PCU050150090 | Balloon Diameter 5 MM | In distribution |
| PCU040300130 | Length 300.0 mm | In distribution |
| PCU060250090 | Length 250.0 mm | In distribution |
| PCU050300090 | Length 300.0 mm | In distribution |
| PCU050250090 | Length 250.0 mm | In distribution |
| PCU060150090 | Length 150.0 mm | In distribution |
| PCU060200130 | Outer Diameter 6.0 mm | In distribution |
| PCU050200130 | Length 200.0 mm | In distribution |
| PCU050200130 | Outer Diameter 5.0 mm | In distribution |
| PCU060150130 | Outer Diameter 6.0 mm | In distribution |
| PCU050150130 | Length 150.0 mm | In distribution |
| PCU050250090 | Balloon Length 250 MM | In distribution |
| PCU070150130 | Length 150.0 mm | In distribution |
| PCU050300130 | Outer Diameter 5.0 mm | In distribution |
| PCU040250130 | Length 250.0 mm | In distribution |
| PCU040250090 | Outer Diameter 4.0 mm | In distribution |
| PCU060200090 | Outer Diameter 6.0 mm | In distribution |
| PCU070150090 | Balloon Length 150 MM | In distribution |
| PCU060150130 | Outer Diameter 6.0 mm | In distribution |
| PCU050300090 | Outer Diameter 5.0 mm | In distribution |
| PCU070250130 | Outer Diameter 7.0 mm | In distribution |
| PCU050250130 | Outer Diameter 5.0 mm | In distribution |
| PCU040150130 | Length 150.0 mm | In distribution |
| PCU050300130 | Outer Diameter 5.0 mm | In distribution |
| PCU060250130 | Outer Diameter 6.0 mm | In distribution |
| PCU070250130 | Length 250.0 mm | In distribution |
| PCU060200130 | Length 200.0 mm | In distribution |
| PCU050300130 | Outer Diameter 5.0 mm | In distribution |
| PCU060200130 | Length 200.0 mm | In distribution |
| PCU040300090 | Outer Diameter 4.0 mm | Withdrawn |
| PCU060150090 | Outer Diameter 6.0 mm | Withdrawn |
| PCU060300090 | Outer Diameter 6.0 mm | Withdrawn |
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 |
|---|---|
| K213631 | 2021-12-15 |
| K121265 | 2012-05-22 |
| K103464 | 2010-12-22 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| ev3, Inc. | 510(k) number | 2020-08-26 | Class II | Under Investigation by firm | Labeling discrepancy for the Rated Burst Pressure (RBP) value. | 4286 devices | 2023-06-09 |
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2016-11-10 | Class II | Process control | Medtronic identified an issue with specific models and lots of the PowerCross.018 Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter. During an unrelated manufacturing inspection of scrapped products, an ou | 315 | 2017-08-02 |
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.