241121
Catheters, Vascular, Embolectomy/Thrombectomy
导管、血管、栓塞切除术/血栓切除术
Penumbra, Inc.·IV·Hong Kong MDACS·Registered October 16, 2024
Device overview
- Risk class
- IV
- Product code
- 10714
- State
- current
- Status
- N/A
- Brand
- INDIGO靛
- Product code detail
- 10714 Catheters, Vascular, Embolectomy/Thrombectomy
Manufacturer (製造商)
- Name
- Penumbra, Inc.Penumbra,Inc.
- Country
- United States美国
- Address
- One Penumbra Place, Alameda, CA 94502, USA半影广场一号,阿拉米达,CA 94502,美国
Authorised representative (AR)
- Phone
- 2893 3118
Regulatory timeline
- Registration date
- October 16, 2024
- Expiry date
- October 15, 2029
Product models
Aspiration Catheter (CAT6, CAT6KIT, CAT8TORQ85, CAT8XTORQ115, CAT8TORQ85KIT, CAT8XTORQ115KIT, CATD, CAT7DKIT, LITNG7XTORQ130, LITNG12XTORQ115, LITNG12HTORQ115, LITNGFHT100BER, LITNGFHT100H1, LITNGFHT115BER, LITNGFHT115H1, LITNGFHT80BER, LITNGFHT80H1, LITNGFXT100BER, LITNGFXT100H1, LITNGFXT80BER, LITNGFXT80H1), Separator (SEPD, SEP6, SEP8, SEP7, SEP12, SEP7D), Aspiration Tubing (IST3, IST4)
抽吸导管(CAT6、CAT6KIT、CAT8TORQ85、CAT8XTORQ115、CAT8TORQ85KIT、CAT8XTORQ115KIT、CATD、CAT7DKIT、LITNG7XTORQ130、LITNG12XTORQ115、LITNG12HTORQ115、LITNGFHT100BER、LITNGFHT100H1、LITNGFHT115BER、LITNGFHT115H1、LITNGFHT80BER、LITNGFHT80H1、LITNGFXT100BER、LITNGFXT100H1、LITNGFXT80BER、LITNGFXT80H1)、分离器(SEPD、SEP6、SEP8、SEP7、SEP12、SEP7D)、抽吸管(IST3、IST4)
About this record
This profile provides complete Hong Kong MDACS registration information for Catheters, Vascular, Embolectomy/Thrombectomy. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.
Product Info: Catheters, Vascular, Embolectomy/Thrombectomy
產品資訊： 导管、血管、栓塞切除术/血栓切除术