VolumeView
1-FEMORAL Catheter KIT (5F, 20 CM), Single Pack
3manufacturers in China registered for this device type
14catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (1), Jiangsu (1), Shandong (1). 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 |
| Bioxin Medical Co., Ltd. | Weihai | Shandong | Contract manufacturer | 8 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Edwards Lifesciences Technology Sarl, United States |
|---|---|
| FDA product code | KRB |
| Device type | Probe, Thermodilution |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1915 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K100739 |
| Record published | 2016-09-03 |
| Record revised | 2018-07-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in a cool, dry place. |
| Packaging | Shipper of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VLV6R520 | Outer Diameter: 5F (1.67mm), Usable Length: 20cm, Compatible Guidewire Dimensions: 0.032″ (0.81mm), 60cm, Vessel Dilator Size: 5F (1.7mm) outer diameter, 15 cm length | In distribution |
| VLV6R416 | Outer Diameter: 4F (1.33mm), Usable Length: 16cm, Compatible Guidewire Dimensions: 0.025″ (0.64mm), 60cm, Vessel Dilator Size: 4F (1.4mm) outer diameter, 10 cm length | In distribution |
| VLV6R5205 | OUTER DIAMETER: 5F (1.67MM), USABLE LENGTH: 20CM, COMPATIBLE GUIDEWIRE DIMENSIONS: 0.032″ (0.81MM), 60CM, VESSEL DILATOR SIZE: 5F (1.7MM) OUTER DIAMETER, 15 CM LENGTH | In distribution |
| VLVFC416 | Outer Diameter: 4F (1.33mm), Usable Length: 16cm, Compatible Guidewire Dimensions: 0.025″ (0.64mm), 60cm, Vessel Dilator Size: 4F (1.4mm) outer diameter, 10 cm length | In distribution |
| VLVCVT5 | NUMBER OF LUER SITES: 3 | In distribution |
| VLV6R4165 | OUTER DIAMETER: 4F (1.33MM), USABLE LENGTH: 16CM, COMPATIBLE GUIDEWIRE DIMENSIONS: 0.025″ (0.64MM), 60CM, VESSEL DILATOR SIZE: 4F (1.4MM) OUTER DIAMETER, 10 CM LENGTH | In distribution |
| VLV8R5205 | OUTER DIAMETER: 5F (1.67MM), USABLE LENGTH: 20CM, COMPATIBLE GUIDEWIRE DIMENSIONS: 0.032″ (0.81MM), 60CM, VESSEL DILATOR SIZE: 5F (1.7MM) OUTER DIAMETER, 15 CM LENGTH | In distribution |
| VLV8R520 | Outer Diameter: 5F (1.67mm), Usable Length: 20cm, Compatible Guidewire Dimensions: 0.032″ (0.81mm), 60cm, Vessel Dilator Size: 5F (1.7mm) outer diameter, 15 cm length | In distribution |
| VLVCVT5 | NUMBER OF LUER SITES: 3 | In distribution |
| VLVFC5205 | OUTER DIAMETER: 5F (1.67MM), USABLE LENGTH: 20CM, COMPATIBLE GUIDEWIRE DIMENSIONS: 0.032″ (0.81MM), 60CM, VESSEL DILATOR SIZE: 5F (1.7MM) OUTER DIAMETER, 15 CM LENGTH | In distribution |
| VLV8R5 | PRESSURE TUBING: 84 IN (213 CM) LENGTH | In distribution |
| VLV8R416 | Outer Diameter: 4F (1.33mm), Usable Length: 16cm, Compatible Guidewire Dimensions: 0.025″ (0.64mm), 60cm, Vessel Dilator Size: 4F (1.4mm) outer diameter, 10 cm length | In distribution |
| VLV8R4165 | OUTER DIAMETER: 4F (1.33MM), USABLE LENGTH: 16CM, COMPATIBLE GUIDEWIRE DIMENSIONS: 0.025″ (0.64MM), 60CM, VESSEL DILATOR SIZE: 4F (1.4MM) OUTER DIAMETER, 10 CM LENGTH | In distribution |
| VLVFC520 | OUTER DIAMETER: 5F (1.67MM), USABLE LENGTH: 20CM, COMPATIBLE GUIDEWIRE DIMENSIONS: 0.032″ (0.81MM), 60CM, VESSEL DILATOR SIZE: 5F (1.7MM) OUTER DIAMETER, 15 CM LENGTH | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| PiCCO Catheter | Pulsion Medical Systems SE | 10 |
| Co-SET+ | Edwards Lifesciences Technology Sarl | 10 |
| ICU Medical | ICU Medical, Inc | 9 |
| PiCCO catheter | Maquet Critical Care AB | 5 |
| Critikit™ | Argon Critical Care Systems Singapore PTE. Ltd. | 3 |
| PiCCO Monitoring Kit | Pulsion Medical Systems SE | 3 |
| Criticath(TM) SP5105HL TD Catheter | Argon Critical Care Systems Singapore PTE. Ltd. | 1 |
| Adler Instrument Company | Adler, Inc. | 1 |
| Co Module w/ cable & accessory | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| Criticath(TM) SP5507S TD Catheter | Argon Critical Care Systems Singapore PTE. Ltd. | 1 |
| Criticath(TM) SP5507 TD Catheter | Argon Critical Care Systems Singapore PTE. Ltd. | 1 |
| Criticath SP5507-13 TD Catheter | Argon Critical Care Systems Singapore PTE. Ltd. | 1 |
Showing 12 of 49. All products under Probe, Thermodilution
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K100739 | 2010-12-07 |
Recalls Naming This Product
4 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 |
|---|---|---|---|---|---|---|
| Edwards Lifesciences Technology Sarl | 510(k) number | 2023-10-04 | Class II | Device Design | Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer. | 33,327 units |
| Edwards Lifesciences Technology Sarl | 510(k) number | 2023-10-04 | Class II | Device Design | Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer. | 6,714 units |
| Edwards Lifesciences Technology Sarl | 510(k) number | 2023-10-04 | Class II | Device Design | Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer. | 1417 units |
| Edwards Lifesciences Technology Sarl | 510(k) number | 2023-10-04 | Class II | Device Design | Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer. | 11,072 units |
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.