200330
IV
current
Catheters, Vascular, Embolectomy/Thrombectomyๅฏผ็ฎกใ่ก็ฎกใๆ ๅกๅ้คๆฏ/่กๆ ๅ้คๆฏ
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
็ขๅ่ณ่จ๏ผ ๅฏผ็ฎกใ่ก็ฎกใๆ ๅกๅ้คๆฏ/่กๆ ๅ้คๆฏ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
10714
Product Code Detail
10714 Catheters, Vascular, Embolectomy/Thrombectomy
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Penumbra, Inc.
Penumbra,Inc.
United States
็พๅฝ
One Penumbra Place, Alameda, CA 94502, USA
ๅๅฝฑๅนฟๅบไธๅท,้ฟๆ็ฑณ่พพ,CA 94502,็พๅฝ
Authorised Representative (AR)
2893 3118
Regulatory Timeline
Registration Date
July 24, 2024
Expiry Date
October 15, 2025
Product Models
Penumbra System - Reperfusion Catheter 3MAX 160 cm (3MAXC), Reperfusion Catheter RED 43 (RED43136, RED43138, RED43160, RED43, RED43167, RED43KIT136, RED43KIT138, RED43KIT160, RED43KIT, RED43KIT167), Reperfusion Catheter RED 62 (RED62132, RED62S, RED62L, RED62KIT132, RED62SKIT, RED62LKIT), Reperfusion Catheter RED 68, 132 cm (RED68, RED68KIT), Reperfusion Catheter RED 72, 132 cm (RED72, RED72KIT), Aspiration Tubing (PRT)
ๅๅฝฑ็ณป็ป - ๅ็ๆณจๅฏผ็ฎก 3MAX 160 cm (3MAXC), ๅ็ๆณจๅฏผ็ฎก RED 43 (RED43136, RED43138, RED43160, RED43, RED43167, RED43KIT136, RED43KIT138, RED43KIT160, RED43KIT, RED43KIT167), ๅ็ๆณจๅฏผ็ฎก RED 62 (RED62132, RED62S, RED62L, RED62KIT132, RED62SKIT, RED62LKIT), ๅ็ๆณจๅฏผ็ฎก RED 68, 132 cm (RED68, RED68KIT), ๅ็ๆณจๅฏผ็ฎก RED 72, 132 cm (RED72, RED72KIT), ๆฝๅธ็ฎก (PRT)