Indigo System
044 Coronary Aspiration Catheter 160 cm Kit
1manufacturer
60catalogue numbers in this listing
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Bioxin Medical Co., Ltd. | Weihai | Shandong | Contract manufacturer | 8 |
Record
| Listed by | Penumbra Inc., United States |
|---|---|
| FDA product code | DXE |
| Device type | Catheter, Embolectomy |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5150 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K142870 |
| Record published | 2016-07-30 |
| Record revised | 2026-02-25 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CAT8TORQ85 | In distribution | |
| CAT8XTORQ115KIT-A | In distribution | |
| CAT6 | In distribution | |
| SEP8-A | In distribution | |
| SEP5-A | In distribution | |
| SEP3 | In distribution | |
| SEP6 | In distribution | |
| CAT12HTORQ85KIT | In distribution | |
| CAT12HTORQ85KIT-A | In distribution | |
| CAT5 | In distribution | |
| CAT8STR85-R | In distribution | |
| CAT8TORQ85-B | In distribution | |
| CATRXKIT160 | In distribution | |
| CAT8XTORQ115 | In distribution | |
| CAT12XTORQ100KIT-A | In distribution | |
| CAT12XTORQ100KIT | In distribution | |
| SEP6-A | In distribution | |
| SEP2 | In distribution | |
| CAT12XTORQ115KIT | In distribution | |
| CAT12HTORQ100KIT-A | In distribution | |
| CAT12XTORQ85KIT-A | In distribution | |
| CAT8TORQ85KIT-R | In distribution | |
| CAT3 | In distribution | |
| CAT12HTORQ115KIT-A | In distribution | |
| CAT8STR85KIT-T | In distribution | |
| CAT8TORQ85-R | In distribution | |
| CAT4 | In distribution | |
| CAT8STR85 | In distribution | |
| CAT8XTORQ100 | In distribution | |
| IST4-A | In distribution | |
| IST3-A | In distribution | |
| CAT2 | In distribution | |
| CAT6-A | In distribution | |
| CAT3KIT-A | In distribution | |
| CAT8XTORQ115KIT-R | In distribution | |
| CAT8TORQ85KIT-T | In distribution | |
| CAT12HTORQ115KIT | In distribution | |
| SEP5 | In distribution | |
| SEP8 | In distribution | |
| CAT12XTORQ85KIT | In distribution | |
| CAT12HTORQ100KIT | In distribution | |
| CAT3-A | In distribution | |
| CAT5KIT-A | In distribution | |
| CAT8STR85KIT-A | In distribution | |
| SEP4 | In distribution | |
| CAT6KIT-A | In distribution | |
| CAT8STR115 | In distribution | |
| CAT8STR85KIT-R | In distribution | |
| CAT8XTORQ115-R | In distribution | |
| IST2 | In distribution | |
| CAT8TORQ85KIT-A | In distribution | |
| SEPC4 | In distribution | |
| IST3 | In distribution | |
| CAT8STR85-B | In distribution | |
| CAT12XTORQ115KIT-A | In distribution | |
| IST2-A | In distribution | |
| SEP3-A | In distribution | |
| CATRXKIT | In distribution | |
| CAT8XTORQ115-B | In distribution | |
| CAT5-A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LeMaitre Embolectomy Catheter | Lemaitre Vascular, Inc. | 68 |
| LMI Arterial Embolectomy Catheter | Lucas Medical, Inc. | 63 |
| Fogarty | Edwards Lifesciences Technology Sarl | 44 |
| Arrow | Teleflex Medical LLC | 28 |
| Bard Latex-free Arterial Embolectomy Catheters | Applied Medical Resources Corp. | 22 |
| Biosensors Embolectomy Catheter | Bioptimal International Pte. Ltd. | 16 |
| Amplatz Goose Neck | Covidien LP | 15 |
| Amplatz Goose Neck™ | ev3, Inc. | 13 |
| LMI Thrombectomy Catheter | Lucas Medical, Inc. | 12 |
| LMI Occlusion Catheter | Lucas Medical, Inc. | 12 |
| Syntel Thrombectomy Catheter | Applied Medical Resources Corp. | 9 |
| Syntel Silicone OTW Embolectomy Catheter | Lemaitre Vascular, Inc. | 9 |
Showing 12 of 88. All products under Catheter, Embolectomy
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.