InfiltraLong 420
InfiltraLong 420 InfiltraLong catheter 19G x 420mm with integrated metal spiral with 10 drill
1manufacturer
2catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Runqiang Medical Instruments Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 9 |
Record
| Listed by | Pajunk Gmbh Medizintechnologie, Germany |
|---|---|
| FDA product code | BSO |
| Device type | Catheter, Conduction, Anesthetic |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5120 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer |
| 510(k) | K080675 |
| Record published | 2026-06-10 |
| Record revised | 2025-06-26 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment humidity 20 to 65 % RH; Storage environment temperature 10 to 30 °C |
| Packaging | Pack of 10 |
| Sizes | Catheter gauge 19 Fr; length 116 mm; needle gauge 18 G |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 001158-00D | Catheter Gauge 19.0 Fr | In distribution |
| 001158-00Z | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 366 |
| Epimed | Epimed International, Inc. | 56 |
| Avanos | Avanos Medical, Inc. | 48 |
| E-Cath Tsui | Pajunk Gmbh Medizintechnologie | 47 |
| Halyard | Avanos Medical, Inc. | 34 |
| Infiltralong | Pajunk Gmbh Medizintechnologie | 25 |
| E-Cath acc. Tsui | Pajunk Gmbh Medizintechnologie | 21 |
| E-Cath Plus acc. Tsui | Pajunk Gmbh Medizintechnologie | 17 |
| Epinaut | Imedicom Co., Ltd. | 16 |
| E-Cath® Plus Tsui® | Pajunk Gmbh Medizintechnologie | 10 |
| E-Cath® II Tsui® | Pajunk Gmbh Medizintechnologie | 9 |
| Spinaut-E | Imedicom Co., Ltd. | 9 |
Showing 12 of 65. All products under Catheter, Conduction, Anesthetic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K172777 | 2018-05-03 |
| K152952 | 2016-07-13 |
| K080675 | 2008-06-20 |
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.