The following data is part of a premarket notification filed by Kossel Medtech (suzhou) Co., Ltd. with the FDA for Selethru Ptca Balloon Dilatation Catheter.
| Device ID | K182699 |
| 510k Number | K182699 |
| Device Name: | Selethru PTCA Balloon Dilatation Catheter |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | Kossel Medtech (Suzhou) Co., Ltd. F3, BLDG 6, No. 8, Jinfeng Road Suzhou, CN 215163 |
| Contact | Zane Wang |
| Correspondent | Jessica Schultz North American Science Associates (NAMSA) 400 Highway 169 South, Suite 500 Minneapolis, MN 55426 |
| Product Code | LOX |
| CFR Regulation Number | 870.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-27 |
| Decision Date | 2018-11-26 |
| Summary: | summary |