The following data is part of a premarket notification filed by Lepu Medical Technology (beijing) Co., Ltd with the FDA for Hoper Ptca Balloon Catheter.
| Device ID | K123473 |
| 510k Number | K123473 |
| Device Name: | HOPER PTCA BALLOON CATHETER |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD 1531 FELTON ROAD South Euclid, OH 44121 -2722 |
| Contact | Arthur Goddard |
| Correspondent | Arthur Goddard LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD 1531 FELTON ROAD South Euclid, OH 44121 -2722 |
| Product Code | LOX |
| CFR Regulation Number | 870.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-13 |
| Decision Date | 2013-08-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00819667020852 | K123473 | 000 |
| 00819667020531 | K123473 | 000 |
| 00819667020524 | K123473 | 000 |
| 00819667020517 | K123473 | 000 |
| 00819667020500 | K123473 | 000 |
| 00819667020494 | K123473 | 000 |
| 00819667020487 | K123473 | 000 |
| 00819667020470 | K123473 | 000 |
| 00819667020463 | K123473 | 000 |
| 00819667020548 | K123473 | 000 |
| 00819667020555 | K123473 | 000 |
| 00819667020630 | K123473 | 000 |
| 00819667020623 | K123473 | 000 |
| 00819667020616 | K123473 | 000 |
| 00819667020609 | K123473 | 000 |
| 00819667020593 | K123473 | 000 |
| 00819667020586 | K123473 | 000 |
| 00819667020579 | K123473 | 000 |
| 00819667020562 | K123473 | 000 |
| 00819667020456 | K123473 | 000 |