The following data is part of a premarket notification filed by Lifetech Scientific (shenzhen) Co., Ltd. with the FDA for Sequre Snare System.
| Device ID | K102484 |
| 510k Number | K102484 |
| Device Name: | SEQURE SNARE SYSTEM |
| Classification | Device, Percutaneous Retrieval |
| Applicant | LIFETECH SCIENTIFIC (SHENZHEN) CO., LTD. LANGSHAN 2ND STREET NANSHAN DISTRICT Shenzheng, Guangdong, CN 518057 |
| Contact | Shi Xiaoli |
| Correspondent | Robert Van Boxtel DEKRA CERTIFICATION B.V. UTRECHTSEWEG 310 Arnhem, NL Nl-6812 Ar |
| Product Code | MMX |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-08-30 |
| Decision Date | 2010-11-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06938370118121 | K102484 | 000 |
| 06938370118022 | K102484 | 000 |
| 06938370118039 | K102484 | 000 |
| 06938370118046 | K102484 | 000 |
| 06938370118053 | K102484 | 000 |
| 06938370118060 | K102484 | 000 |
| 06938370118077 | K102484 | 000 |
| 06938370118084 | K102484 | 000 |
| 06938370118091 | K102484 | 000 |
| 06938370118107 | K102484 | 000 |
| 06938370118114 | K102484 | 000 |
| 06938370118015 | K102484 | 000 |