Pinnacle
PINNACLE R/O II HiFlo Introducer Sheath with Radiopaque Marker
13manufacturers in China registered for this device type
90catalogue numbers in this listing
28510(k) clearances naming this product code
29recalls on this code
Who Else Makes It
Concentrated in Jiangsu (5), Beijing (3), Shanghai (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Tianjin Demax Medical Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 5 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Shanghai INT Medical Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Lepu Medical Technology (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Beijing Target Medical Technologies Inc. | Beijing | Beijing | Contract manufacturer | 7 |
| Beijing Demax Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 5 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
| Tianjin Ethylene Oxide Sterilization Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 4 |
| Shanghai Microport EP Medtech Co., Ltd. | Shanghai | Shanghai | Manufacturer | 3 |
| Becton Dickinson Medical Devices Co., Ltd. Suzhou | Suzhou | Jiangsu | Contract manufacturer | 2 |
| Cardiocycle Medical(Suzhou) Co., Ltd. | Suzhou | Jiangsu | Complaint-file establishment | 1 |
Showing 12 of 13. All 13 manufacturers in China registered for Introducer, Catheter
Record
| Listed by | Terumo Corp., Japan |
|---|---|
| FDA product code | DYB |
| Device type | Introducer, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1340 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2024-03-20 (version 6) |
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 |
| Storage | Special storage condition: Avoid direct sunlight.; Special storage condition: Do not store at extreme temperature and humidity. |
| Packaging | Carton of 10, shelfbox of 10 |
| Sizes | Catheter gauge 4 to 11 Fr; length 4 to 25 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RSS704 | Catheter Gauge 7 Fr | In distribution |
| RSS804 | Contents: Sheath and Dilator | In distribution |
| RSB811 | Guidewire: 0.038 Inch | In distribution |
| RSB512 | Catheter Gauge 5 Fr | In distribution |
| RSB911 | Length 6 cm | In distribution |
| RSB902 | Length 10 cm | In distribution |
| RSS401 | Contents: Sheath, Dilator, Mini Guidewire (0.035 Inch) and Guide Inserter | In distribution |
| RSS005 | Catheter Gauge 10 Fr | In distribution |
| 10-2533 | Length 10 cm | In distribution |
| RSB402 | Catheter Gauge 4 Fr | In distribution |
| RSB612 | Guidewire: 0.038 Inch | In distribution |
| RSB901 | Catheter Gauge 9 Fr | In distribution |
| RSB702 | Length 10 cm | In distribution |
| RSS505 | Catheter Gauge 5 Fr | In distribution |
| RSS603 | Contents: Sheath and Dilator | In distribution |
| RSS904 | Contents: Sheath and Dilator | In distribution |
| RSS001 | Guidewire Compatibility: 0.038 Inch | In distribution |
| 10-2532 | Guidewire Compatibility: 0.038 Inch | In distribution |
| 10-2534 | Length 10 cm | In distribution |
| RSS105 | Catheter Gauge 11 Fr | In distribution |
| RSS502 | Contents: Sheath, Dilator, Mini Guidewire (0.038 Inch) and Guide Inserter | In distribution |
| RSS606 | Length 25 cm | In distribution |
| RSB412 | Catheter Gauge 4 Fr | In distribution |
| RSS404 | Guidewire Compatibility: 0.035 Inch | In distribution |
| RSS802 | Contents: Sheath, Dilator, Mini Guidewire (0.038 Inch) and Guide Inserter | In distribution |
| RSB812 | Guidewire: 0.038 Inch | In distribution |
| RSB705H | Catheter Gauge 7 Fr | In distribution |
| RSB802 | Catheter Gauge 8 Fr | In distribution |
| RSS903 | Catheter Gauge 9 Fr | In distribution |
| RSS103 | Catheter Gauge 11 Fr | In distribution |
| RSS506 | Length 25 cm | In distribution |
| RSS602 | Catheter Gauge 6 Fr | In distribution |
| RSS102 | Catheter Gauge 11 Fr | In distribution |
| RSB401 | Length 6 cm | In distribution |
| RSB601 | Guidewire Compatibility: 0.038 Inch | In distribution |
| RSS002 | Length 10 cm | In distribution |
| RSB411 | Guidewire: 0.035 Inch | In distribution |
| RSS403 | Catheter Gauge 4 Fr | In distribution |
| RSS905 | Catheter Gauge 9 Fr | In distribution |
| RSS601 | Guidewire Compatibility: 0.038 Inch | In distribution |
| RSB801 | Length 6 cm | In distribution |
| RSS504 | Guidewire Compatibility: 0.038 Inch | In distribution |
| RSB805H | Length 4 cm | In distribution |
| RSS706 | Catheter Gauge 7 Fr | In distribution |
| RSB712 | Guidewire Compatibility: 0.038 Inch | In distribution |
| RSS801 | Guidewire Compatibility: 0.038 Inch | In distribution |
| RSB701 | Guidewire Compatibility: 0.038 Inch | In distribution |
| RSB503 | Catheter Gauge 5 Fr | In distribution |
| RSS805 | Catheter Gauge 8 Fr | In distribution |
| 10-2032 | Catheter Gauge 6 Fr | In distribution |
| RSB804H | Guidewire: 0.035 Inch | In distribution |
| RSS703 | Length 10 cm | In distribution |
| RSS702 | Catheter Gauge 7 Fr | In distribution |
| RSS906 | Length 25 cm | In distribution |
| RSB502 | Length 10 cm | In distribution |
| RSS806 | Catheter Gauge 8 Fr | In distribution |
| RSS705 | Contents: Sheath and Dilator | In distribution |
| RSB912 | Catheter Gauge 9 Fr | In distribution |
| RSB711 | Catheter Gauge 7 Fr | In distribution |
| RSS604 | Contents: Sheath and Dilator | In distribution |
| 10-2034 | Guidewire Compatibility: 0.038 Inch | In distribution |
| 10-2033 | Catheter Gauge 7 Fr | In distribution |
| RSS803 | Guidewire Compatibility: 0.038 Inch | In distribution |
| RSB511 | Guidewire: 0.038 Inch | In distribution |
| RSS104 | Contents: Sheath and Dilator | In distribution |
| RSB903 | Length 25 cm | In distribution |
| RSS106 | Length 25 cm | In distribution |
| RSB611 | Guidewire Compatibility: 0.038 Inch | In distribution |
| RSB602 | Length 10 cm | In distribution |
| RSS003 | Contents: Sheath and Dilator | In distribution |
| 10-2031 | Guidewire Compatibility: 0.038 Inch | In distribution |
| RSS503 | Guidewire Compatibility: 0.038 Inch | In distribution |
| RSS004 | Length 10 cm | In distribution |
| 10-2531 | Guidewire: 0.038 Inch | In distribution |
| RSB403 | Length 25 cm | In distribution |
| RSB605H | Catheter Gauge 6 Fr | In distribution |
| RSB604H | Guidewire Compatibility: 0.038 Inch | In distribution |
| RSS901 | Length 10 cm | In distribution |
| RSS902 | Catheter Gauge 9 Fr | In distribution |
| RSS006 | Contents: Sheath and Dilator | In distribution |
| RSB603 | Length 25 cm | In distribution |
| RSS101 | Catheter Gauge 11 Fr | In distribution |
| RSS501 | Catheter Gauge 5 Fr | In distribution |
| RSS402 | Length 10 cm | In distribution |
| RSS605 | Catheter Gauge 6 Fr | In distribution |
| RSB803 | Catheter Gauge 8 Fr | In distribution |
| RSS701 | Catheter Gauge 7 Fr | In distribution |
| RSB501 | Catheter Gauge 5 Fr | In distribution |
| RSB703 | Guidewire Compatibility: 0.038 Inch | In distribution |
| RSB704H | Length 4 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Demax | Beijing Demax Medical Technology Co., Ltd. | 2,841 |
| Arrow | Teleflex Medical LLC | 1,036 |
| Prelude IDeal™ | Merit Medical Systems, Inc. | 294 |
| Fast-Cath™ | St. Jude Medical | 213 |
| Flexor | Cook Incorporated | 182 |
| Prelude Ease™ | Merit Medical Systems, Inc. | 176 |
| Performer | Cook Incorporated | 174 |
| VSI | Teleflex Medical LLC | 154 |
| Peel-Away | Cook Incorporated | 153 |
| OptiSeal™ | Greatbatch Medical | 127 |
| Brilliant | Lepu Medical Technology (Beijing) Co., Ltd. | 122 |
| Super Sheath | Togo Medikit Co., Ltd. | 122 |
Showing 12 of 439. All products under Introducer, Catheter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K193125 | 2020-01-06 |
| K181237 | 2018-08-03 |
| K173831 | 2018-05-08 |
| K172995 | 2017-11-21 |
| K171491 | 2017-10-05 |
| K152173 | 2015-12-01 |
| K142183 | 2014-11-21 |
| K122980 | 2012-12-11 |
| K111606 | 2011-10-03 |
| K102008 | 2010-07-21 |
| K091329 | 2009-05-29 |
| K082847 | 2008-10-29 |
| K082644 | 2008-09-18 |
| K081045 | 2008-05-28 |
| K081046 | 2008-05-21 |
| K080415 | 2008-03-07 |
| K062446 | 2006-10-23 |
| K062858 | 2006-10-20 |
| K060666 | 2006-06-29 |
| K052185 | 2005-09-06 |
| K051601 | 2005-08-04 |
| K033681 | 2003-12-11 |
| K012854 | 2001-11-21 |
| K012812 | 2001-11-14 |
| K003424 | 2000-11-21 |
| K984260 | 1999-01-26 |
| K954234 | 1995-11-27 |
| K863139 | 1986-10-10 |
Recalls
3 of these are 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 |
|---|---|---|---|---|---|
| 2026-06-15 | Class II | Under Investigation by firm | Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire. | 7,490 units | |
| 2019-04-26 | Class I | Device Design | There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath. | 1481 | 2020-09-22 |
| 2019-04-26 | Class I | Device Design | There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath. | 2228 | 2020-09-22 |
| 2019-04-26 | Class I | Device Design | There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath. | 1431 | 2020-09-22 |
| 2017-09-12 | Class II | Process control | The tucking depth feature of this catheter introducer is marginally outside the upper specification. | 33 | 2018-08-31 |
| 2017-06-07 | Class II | Nonconforming Material/Component | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may | 2019-04-25 | |
| 2017-06-07 | Class II | Nonconforming Material/Component | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may | 2019-04-25 | |
| 2017-06-07 | Class II | Nonconforming Material/Component | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may | 2019-04-25 | |
| 2017-06-07 | Class II | Nonconforming Material/Component | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may | 2019-04-25 | |
| 2017-06-07 | Class II | Nonconforming Material/Component | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may | 2019-04-25 | |
| 2017-06-07 | Class II | Nonconforming Material/Component | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may | 2019-04-25 | |
| 2017-06-07 | Class II | Nonconforming Material/Component | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may | 2019-04-25 | |
| 2017-06-07 | Class II | Nonconforming Material/Component | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may | 2019-04-25 | |
| 2017-06-07 | Class II | Nonconforming Material/Component | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may | 2019-04-25 | |
| 2017-06-07 | Class II | Nonconforming Material/Component | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may | 2019-04-25 | |
| 2017-06-07 | Class II | Nonconforming Material/Component | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may | 2019-04-25 | |
| 2017-06-07 | Class II | Nonconforming Material/Component | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may | 2019-04-25 | |
| 2017-06-07 | Class II | Nonconforming Material/Component | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may | 2019-04-25 | |
| 2017-06-07 | Class II | Nonconforming Material/Component | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may | 2019-04-25 | |
| 2017-06-07 | Class II | Nonconforming Material/Component | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may | 2019-04-25 | |
| 2017-06-07 | Class II | Nonconforming Material/Component | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may | 2019-04-25 | |
| 2017-06-07 | Class II | Nonconforming Material/Component | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may | 2019-04-25 | |
| 2016-03-16 | Class II | Device Design | Terumo Medical is initiating this recall due to complaints of valve leakage that have been related to a manufacturing issue. If affected introducer sheaths are used, there is possible risk of incremental blood loss through the valve. | 1,370,995 eaches have been distributed to the field | 2017-01-27 |
| 2015-11-06 | Class II | Other | Based on internal investigation and testing that revealed the distal end of certain lots of Terumo Medical Destination products may not contain the labeled 5 cm of coating. While there have been no complaints or patient related incidents re | 5,252 eaches | 2017-05-12 |
| 2013-05-30 | Class II | Error in labeling | Medical devices were incorrectly labeled with extended expiration dates. | 550 units | 2013-10-30 |
| 2013-05-30 | Class II | Error in labeling | Medical devices were incorrectly labeled with extended expiration dates. | 20 units | 2013-10-30 |
| 2010-06-24 | Not classified | Equipment maintenance | Molding defect in destination product that render the device unusable. | 37 units | 2011-07-07 |
| 2010-06-24 | Not classified | Equipment maintenance | Molding defect in destination product that render the device unusable. | 7 units | 2011-07-07 |
| 2010-06-24 | Not classified | Equipment maintenance | Molding defect in destination product that render the device unusable. | 214 units | 2011-07-07 |
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.