Hemosphere
Pressure Cable
1manufacturer
2catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
Record
| Listed by | Edwards Lifesciences Technology Sarl, United States |
|---|---|
| FDA product code | QAQ |
| Device type | Adjunctive Predictive Cardiovascular Indicator |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2210 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K180881 |
| Record published | 2019-01-04 |
| Record revised | 2025-09-11 (version 8) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Special storage condition: Temperature: -18 to 45C, Relative Humidity: 90% non-condensing at 45C, Altitude: 0 to 20,000 feet (6096 m) |
| Sizes | Length 15.2 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HEMPSC100 | Pressure Cable: Length: 3 m (10 ft) and 4.6 m (15 ft) | In distribution |
| HEMDPT1000 | Length 15.2 in | In distribution |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242518 | 2025-05-15 |
| K230057 | 2023-06-08 |
| K203224 | 2021-07-30 |
| DEN160044 | 2018-03-16 |
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.