Labsystem™ PRO
CLEARSIGN™ Amplifier to CARTO® 3 System Quick Connect Stimulator Adaptor Cable
4manufacturers in China registered for this device type
53catalogue numbers in this listing
2510(k) clearances naming this product code
1recall
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 |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
Record
| Listed by | Boston Scientific Corporation, United States |
|---|---|
| FDA product code | DRQ |
| Device type | Amplifier And Signal Conditioner, Transducer Signal |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2060 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2019-12-13 |
| Record revised | 2024-12-23 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2020-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M00420013300 | 15 m Effective Length | In distribution |
| M00420012530 | 3 m Effective Length | In distribution |
| M0042002024R0 | In distribution | |
| M00420012430 | 15 m Effective Length | In distribution |
| M0042002022H0 | In distribution | |
| M00420019740 | 6 m Effective Length | In distribution |
| M00420019700 | In distribution | |
| M0042002022D0 | In distribution | |
| M00420010010 | In distribution | |
| M0042003380 | In distribution | |
| M00420012550 | 15 m Effective Length | In distribution |
| M004LSPRO080D0 | In distribution | |
| M0042002023H0 | In distribution | |
| M00420012510 | 6 m Effective Length | In distribution |
| M00420020220 | In distribution | |
| M00420013280 | 3 m Effective Length | In distribution |
| M0042002023R0 | In distribution | |
| M00420012410 | 3 m Effective Length | In distribution |
| M00420012540 | 6 m Effective Length | In distribution |
| M0042004670 | In distribution | |
| M00420020210 | In distribution | |
| M00420010000 | In distribution | |
| M0042002024H0 | In distribution | |
| M0042002023D0 | In distribution | |
| M00420020230 | In distribution | |
| M0042002021H0 | In distribution | |
| M00420012420 | 6 m Effective Length | In distribution |
| M00420019690 | 3 m Effective Length | In distribution |
| M00420020240 | In distribution | |
| M0042002021D0 | In distribution | |
| M00420019680 | 3 m Effective Length | In distribution |
| M004LSPRO160D0 | In distribution | |
| M00420012300 | In distribution | |
| M00420013290 | 6 m Effective Length | In distribution |
| M0042002024D0 | In distribution | |
| M00420012520 | 15 m Effective Length | In distribution |
| M00420019750 | 6 m Effective Length | In distribution |
| M0042002022R0 | In distribution | |
| M00420012500 | 3 m Effective Length | In distribution |
| M0042002021R0 | In distribution | |
| M00420010770 | In distribution | |
| M0042001268D0 | Withdrawn | |
| M0042001232R0 | Withdrawn | |
| M0042001266R0 | Withdrawn | |
| M0042001232H0 | Withdrawn | |
| M0042001268H0 | Withdrawn | |
| M0042001267D0 | Withdrawn | |
| M0042001267R0 | Withdrawn | |
| M0042001232D0 | Withdrawn | |
| M0042001266D0 | Withdrawn | |
| M0042001266H0 | Withdrawn | |
| M0042001267H0 | Withdrawn | |
| M0042001268R0 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RXi® Mini Navvus Interface Cable | Acist Medical Systems, Inc. | 3 |
| Acist RXi® Mini System Overpack | Acist Medical Systems, Inc. | 2 |
| IBP Module | Philips Medizin Systeme Böblingen GmbH | 1 |
| Acist RXi® Mini Mount | Acist Medical Systems, Inc. | 1 |
| Acist RXi® Mini Navvus Interface | Acist Medical Systems, Inc. | 1 |
| Monitor Input Cable, Mikro-Cath to EP-Tracer System | Millar LLC. | 1 |
| IDS With Intergrated MIB | Draeger Medical Systems, Inc. | 1 |
| Pressure Control Unit PCU-2000 | Millar LLC. | 1 |
| MIB II Protocol Converter | Draeger Medical Systems, Inc. | 1 |
| Acist RXi® Mini Processing Unit | Acist Medical Systems, Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K152693 | 2015-10-21 |
| K150235 | 2015-04-22 |
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 |
|---|---|---|---|---|---|
| 2015-06-02 | Class II | Software design | Boston Scientific has received complaints indicating that, when using the blood pressure (BP) channels on the CLEARSIGN II Amplifier, the surface Electrocardiogram (ECG) channels become over-written to a variable degree, with the result tha | 43 units | 2016-10-26 |
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.