Koala® Cables
Cables to IUP catheters: Litton Air-Shields Fetascan 1400
2manufacturers in China registered for this device type
9catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
Record
| Listed by | Clinical Innovations, LLC, United States |
|---|---|
| FDA product code | HFN |
| Device type | Transducer, Pressure, Intrauterine |
| Device class | Class 2 |
| Regulation | 21 CFR 884.2700 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K974389 |
| Record published | 2016-09-01 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPC-5080 | In distribution | |
| IPC-5060 | In distribution | |
| IPC-5016 | In distribution | |
| IPC-5018 | In distribution | |
| IPC-5061 | In distribution | |
| IPC-5050 | In distribution | |
| IPC-5012 | In distribution | |
| IPC-5014 | In distribution | |
| IPC-5090 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Intran | Utah Medical Products, Inc. | 8 |
| Koala® | Clinical Innovations, LLC | 2 |
| Advanced Fetal Monitor | Advanced Instrumentations, Inc. | 1 |
| Transducer, Pressure, Intrauterine | Philips Medizin Systeme Böblingen GmbH | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250897 | 2025-05-22 |
| K974389 | 1998-02-19 |
| K973746 | 1997-11-24 |
| K954955 | 1996-04-17 |
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.