EverFlex
Stent PRB35-08-150-080 Protege EF V10
6manufacturers in China registered for this device type
53catalogue numbers in this listing
12510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Jiangsu (3), Zhejiang (2), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 20 |
| Hangzhou AGS MedTech Co., Ltd. | Hangzhou | Zhejiang | Repacker / relabeller | 19 |
| Dongguan TT Medical, Inc. | Dongguan | Guangdong | Manufacturer | 4 |
| LEO Medical Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 4 |
Record
| Listed by | ev3, Inc., United States |
|---|---|
| FDA product code | FGE |
| Device type | Stents, Drains And Dilators For The Biliary Ducts |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5010 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K060057 |
| Record published | 2015-05-27 |
| Record revised | 2024-12-11 (version 9) |
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 |
| Sizes | Catheter gauge 6 Fr; length 20 to 200 mm |
| Distribution end date | 2025-06-23 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PRB35-08-020-120 | Length 20.0 mm | In distribution |
| PRB35-06-150-080 | Length 150.0 mm | In distribution |
| PRB35-06-060-080 | Catheter Gauge 6.0 Fr | In distribution |
| PRB35-08-200-120 | Length 200.0 mm | In distribution |
| PRB35-08-080-080 | Length 80.0 mm | In distribution |
| PRB35-06-100-080 | Catheter Gauge 6.0 Fr | In distribution |
| PRB35-06-120-080 | Length 120.0 mm | In distribution |
| PRB35-06-080-080 | Length 80.0 mm | In distribution |
| PRB35-06-080-120 | Catheter Gauge 6.0 Fr | In distribution |
| PRB35-06-030-120 | Length 30.0 mm | In distribution |
| PRB35-08-150-080 | Catheter Gauge 6.0 Fr | Withdrawn |
| PRB35-06-030-080 | Length 30.0 mm | Withdrawn |
| PRB35-07-120-080 | Length 120.0 mm | Withdrawn |
| PRB35-07-100-120 | Length 100.0 mm | Withdrawn |
| PRB35-07-080-120 | Catheter Gauge 6.0 Fr | Withdrawn |
| PRB35-06-200-120 | Catheter Gauge 6.0 Fr | Withdrawn |
| PRB35-07-040-120 | Catheter Gauge 6.0 Fr | Withdrawn |
| PRB35-07-040-080 | Length 40.0 mm | Withdrawn |
| PRB35-06-040-120 | Catheter Gauge 6.0 Fr | Withdrawn |
| PRB35-08-020-080 | Catheter Gauge 6.0 Fr | Withdrawn |
| PRB35-07-150-080 | Catheter Gauge 6.0 Fr | Withdrawn |
| PRB35-07-080-080 | Length 80.0 mm | Withdrawn |
| PRB35-08-150-120 | Catheter Gauge 6.0 Fr | Withdrawn |
| PRB35-07-020-120 | Catheter Gauge 6.0 Fr | Withdrawn |
| PRB35-07-020-080 | Length 20.0 mm | Withdrawn |
| PRB35-08-060-120 | Catheter Gauge 6.0 Fr | Withdrawn |
| PRB35-07-100-080 | Catheter Gauge 6.0 Fr | Withdrawn |
| PRB35-07-150-120 | Length 150.0 mm | Withdrawn |
| PRB35-07-060-080 | Length 60.0 mm | Withdrawn |
| PRB35-08-030-080 | Catheter Gauge 6.0 Fr | Withdrawn |
| PRB35-06-060-120 | Length 60.0 mm | Withdrawn |
| PRB35-07-150-080 | Catheter Gauge 6.0 Fr | Withdrawn |
| PRB35-07-060-120 | Length 60.0 mm | Withdrawn |
| PRB35-08-040-120 | Catheter Gauge 6.0 Fr | Withdrawn |
| PRB35-06-100-120 | Catheter Gauge 6.0 Fr | Withdrawn |
| PRB35-06-020-080 | Catheter Gauge 6.0 Fr | Withdrawn |
| PRB35-08-120-120 | Length 120.0 mm | Withdrawn |
| PRB35-06-150-120 | Length 150.0 mm | Withdrawn |
| PRB35-07-030-120 | Catheter Gauge 6.0 Fr | Withdrawn |
| PRB35-08-040-080 | Catheter Gauge 6.0 Fr | Withdrawn |
| PRB35-07-030-080 | Catheter Gauge 6.0 Fr | Withdrawn |
| PRB35-06-120-120 | Length 120.0 mm | Withdrawn |
| PRB35-08-100-120 | Length 100.0 mm | Withdrawn |
| PRB35-08-030-120 | Catheter Gauge 6.0 Fr | Withdrawn |
| PRB35-06-020-120 | Catheter Gauge 6.0 Fr | Withdrawn |
| PRB35-08-060-080 | Catheter Gauge 6.0 Fr | Withdrawn |
| PRB35-07-200-120 | Length 200.0 mm | Withdrawn |
| PRB35-08-120-080 | Catheter Gauge 6.0 Fr | Withdrawn |
| PRB35-08-080-120 | Catheter Gauge 6.0 Fr | Withdrawn |
| PRB35-08-100-080 | Catheter Gauge 6.0 Fr | Withdrawn |
| PRB35-07-120-120 | Catheter Gauge 6.0 Fr | Withdrawn |
| PRB35-06-040-080 | Catheter Gauge 6.0 Fr | Withdrawn |
| PRB35-07-120-080 | Length 120.0 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Zimmon | Cook Ireland Ltd | 213 |
| Single Use Biliary Drainage Stent V | Olympus Medical Systems Corp. | 181 |
| Mustang™ | Boston Scientific Corporation | 167 |
| Geenen | Cook Ireland Ltd | 158 |
| Cotton-Leung | Cook Ireland Ltd | 144 |
| Advanix™ Pancreatic Stent | Boston Scientific Corporation | 135 |
| Single Use Biliary Stent V | Olympus Medical Systems Corp. | 106 |
| Single-use Balloon Dilatation Catheter | LEO Medical Co., Ltd. | 102 |
| Biliary Plastic Stent Set | Micro-Tech (Nanjing) Co., Ltd. | 90 |
| Biliary Plastic Stent | Micro-Tech (Nanjing) Co., Ltd. | 90 |
| M-Drain | Mermaid Medical A/S | 86 |
| Advanix™ Biliary | Boston Scientific Corporation | 84 |
Showing 12 of 212. All products under Stents, Drains And Dilators For The Biliary Ducts
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K072301 | 2008-03-18 |
| K061566 | 2006-08-31 |
| K060057 | 2006-03-08 |
| K051379 | 2005-06-17 |
| K050725 | 2005-04-20 |
| K043243 | 2004-12-09 |
| K042204 | 2004-08-23 |
| K040653 | 2004-04-28 |
| K033314 | 2003-11-21 |
| K033134 | 2003-11-17 |
| K032580 | 2003-10-22 |
| K032206 | 2003-08-08 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| ev3, Inc. | 510(k) number | 2010-03-31 | Not classified | Mixed-up of materials/components | ev3 is conducting a voluntary recall on three lots of the Protg EverFlex” Biliary Stent System. They determined that a lot of 120mm Protg EverFlex” Biliary Stent system may contain a 150mm length Self-Expanding stent and two lots o 150mm P | 19 | 2012-03-08 |
| ev3, Inc. | 510(k) number | 2009-11-06 | Not classified | Labeling mix-ups | ev3 has determined that a lot of 150mm Protg EverFlex Biliary Stent System contains a 100mm length Self-Expanding stent. The implantation of a stent 50mm shorter than expected may not cover the full length of the target lesion and may requ | 6 (United States) and 6 (Outside United States) | 2012-03-08 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2010-10-30 | Not classified | Packaging process control | Mislabeled size: Specific Protg GPS lots have product labeling that does not match the actual stent sizes contained in the packages. The affected product outer packaging is labeled as a 12 mm x 60 mm Protg GPS stent but contains a 14 mm x 6 | 30 | 2012-03-29 |
| 2009-06-10 | Not classified | Labeling mix-ups | ev3 Inc. is conducting a voluntary recall of specific lots of the Protege GPS Self-Expanding Stent System because labeling did not match the actual stent size contained in the package. The affected product was labeled as a 6mm x 80mm Prot | 2 | 2011-12-11 |
| 2009-06-10 | Not classified | Labeling mix-ups | ev3 Inc. is conducting a voluntary recall of specific lots of the Protege GPS Self-Expanding Stent System because labeling did not match the actual stent size contained in the package. The affected product was labeled as a 6mm x 80mm Prot | 2 | 2011-12-11 |
| 2009-06-10 | Not classified | Labeling mix-ups | ev3 Inc. is conducting a voluntary recall of specific lots of the Protege GPS Self-Expanding Stent System because labeling did not match the actual stent size contained in the package. The affected product was labeled as a 6mm x 80mm Prot | 4 | 2011-12-11 |
| 2009-06-10 | Not classified | Labeling mix-ups | ev3 Inc. is conducting a voluntary recall of specific lots of the Protege GPS Self-Expanding Stent System because labeling did not match the actual stent size contained in the package. The affected product was labeled as a 6mm x 80mm Prot | 5 | 2011-12-11 |
| 2008-07-01 | Not classified | Employee error | ev3, Inc. has determined that specific lots of the Visi-Pro” BE Stent system may not have adequate securement of the stent to the delivery system and may have a larger diameter/profile than intended. | 212 | 2011-12-10 |
| 2008-07-01 | Not classified | Employee error | ev3, Inc. has determined that specific lots of the Visi-Pro” BE Stent system may not have adequate securement of the stent to the delivery system and may have a larger diameter/profile than intended. | 66 | 2011-12-10 |
| 2008-04-22 | Not classified | Employee error | A Protege PS Biliary stent system was mislabeled. The mislabeling resulted in a 9 mm diameter, 60 mm length stent being labeled as a 6 mm x 60 mm stent. | 1 | 2011-12-10 |
| 2008-04-22 | Not classified | Employee error | A Primus GPS Biliary Stent System was mislabeled. The mislabeling resulted in a 8 mm diameter, 27 mm length stent being labeled as a 8 mm x 37 mm stent. | 1 Unit | 2011-12-10 |
| 2008-01-18 | Not classified | Labeling Change Control | Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed. | 30 | 2008-11-04 |
| 2008-01-18 | Not classified | Labeling Change Control | Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed. | 70 | 2008-11-04 |
| 2008-01-18 | Not classified | Labeling Change Control | Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed. | 23 | 2008-11-04 |
| 2008-01-18 | Not classified | Labeling Change Control | Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed. | 12 | 2008-11-04 |
| 2008-01-18 | Not classified | Labeling Change Control | Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed. | 389 | 2008-11-04 |
| 2008-01-18 | Not classified | Labeling Change Control | Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed. | 7 | 2008-11-04 |
| 2008-01-18 | Not classified | Labeling Change Control | Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed. | 22 | 2008-11-04 |
| 2008-01-18 | Not classified | Labeling Change Control | Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed. | 66 | 2008-11-04 |
| 2008-01-18 | Not classified | Labeling Change Control | Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed. | 11 | 2008-11-04 |
| 2008-01-18 | Not classified | Labeling Change Control | Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed. | 2 | 2008-11-04 |
| 2008-01-18 | Not classified | Labeling Change Control | Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed. | 107 | 2008-11-04 |
| 2008-01-18 | Not classified | Labeling Change Control | Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed. | 203 | 2008-11-04 |
| 2006-12-06 | Not classified | Other | Two individual ev3 Protege GPS Biliary Stent System devices were incorrectly labeled as SERB65-09-60-120 and the actual device is SERB65-12-60-80. Length is shorter than expected. | 2 | 2007-02-03 |
| 2006-03-08 | Not classified | Other | A Primus device labeled (pouch and box) as a BXB35-05-17-120 contained a 6mm x 20mm catheter instead of the intended 5mm x 20mm catheter. | 29 | 2007-02-03 |
| 2006-02-27 | Not classified | Other | Mispackaging-Protege GPS SER6-9-60-125 devices were incorrectly packaged as SER6-7-80-135. Diameter is larger than expected. | 4 | 2006-12-26 |
| 2005-12-29 | Not classified | Other | IntraStent product S15-36 (P/N 90-1341-02) lot 494428 was labeled as IntraStent product S15-26 (P/N 90-1341-001) | 6 devices | 2006-12-26 |
| 2005-08-01 | Not classified | Other | A Primus device was labeled as a BXB 35 09-37-75 but contained a BXB35 07-27-75 stent. | 18 devices | 2006-12-31 |
| 2005-06-10 | Not classified | Other | A total of 3 devices from 3 separate lots were re-labeled with incorrect stent dimensions (diameter and length) and distributed to 2 hospitals. Affected product was retrieved by an ev3 representative. | 1 | 2005-11-17 |
| 2005-06-10 | Not classified | Other | A total of 3 devices from 3 separate lots were re-labeled with incorrect stent dimensions (diameter and length) and distributed to 2 hospitals. Affected product was retrieved by an ev3 representative. | 1 | 2005-11-17 |
| 2005-06-10 | Not classified | Other | A total of 3 devices from 3 separate lots were re-labeled with incorrect stent dimensions (diameter and length) and distributed to 2 hospitals. Affected product was retrieved by an ev3 representative. | 1 | 2005-11-17 |
| 2004-09-01 | Not classified | Other | A customer complaint received indicated that a Protg stent, PN SERB65-09-30-120 was found in a pouch that was not properly sealed. The Protg GPS Stent System is ‘double barrier’ packaged and consists of a sealed inner tray in a sealed pouc | 5 systems | 2005-11-03 |
| 2004-07-09 | Not classified | Other | Ev3 had received customer complaints indicating that the stent device could not be used with an.035′ guidewire. An investigation found that 6Fr, 135 cm (.018′) stent system were labeled as a 120 cm (.035′) stent system and that 6Fr 120 cm | 10 | 2006-12-28 |
| 2004-07-09 | Not classified | Other | Ev3 had received customer complaints indicating that the stent device could not be used with an.035′ guidewire. An investigation found that 6Fr, 135 cm (.018′) stent system were labeled as a 120 cm (.035′) stent system and that 6Fr 120 cm | 11 | 2006-12-28 |
| 2004-01-29 | Not classified | Other | After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time. | 446 | 2005-11-08 |
| 2004-01-29 | Not classified | Other | After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time. | 446 | 2005-11-08 |
| 2004-01-29 | Not classified | Other | After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time. | 446 | 2005-11-08 |
| 2004-01-29 | Not classified | Other | After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time. | 446 | 2005-11-08 |
| 2004-01-29 | Not classified | Other | After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time. | 446 | 2005-11-08 |
| 2004-01-29 | Not classified | Other | After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time. | 446 | 2005-11-08 |
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.