Medical Device Division · registration 240211ActivePenumbra PX SLIM Delivery Microcatheter (PXSLIMSTR, PXSLIM045, PXSLIM090, PXSLIM130, PXSLIM160STR, PXSLIM160045, PXSLIM160090, PXSLIM160130), Penumbra Velocity Delivery Microcatheter (VEL150045, VEL150090, VEL150130, VEL150STR, VEL160045, VEL160090, VEL160130, VEL160STR), Penumbra LANTERN Delivery Microcatheter (PXSLIMLAN115STR, PXSLIMLAN115T130, PXSLIMLAN115T45, PXSLIMLAN115T90, PXSLIMLAN135STR, PXSLIMLAN135T130, PXSLIMLAN135T45, PXSLIMLAN135T90, PXSLIMLAN150STR, PXSLIMLAN150T130, PXSLIMLAN150T45, PXSLIMLAN150T90, PXSLIMLAN160STR, PXSLIMLAN160T130, PXSLIMLAN160T45, PXSLIMLAN160T90)
Hong KongCatheters, Vascular, MicroflowClass IVPenumbra, Inc.
Official record identity
- MDACS listing number
- 240211
- Model name
- Penumbra PX SLIM Delivery Microcatheter (PXSLIMSTR, PXSLIM045, PXSLIM090, PXSLIM130, PXSLIM160STR, PXSLIM160045, PXSLIM160090, PXSLIM160130), Penumbra Velocity Delivery Microcatheter (VEL150045, VEL150090, VEL150130, VEL150STR, VEL160045, VEL160090, VEL160130, VEL160STR), Penumbra LANTERN Delivery Microcatheter (PXSLIMLAN115STR, PXSLIMLAN115T130, PXSLIMLAN115T45, PXSLIMLAN115T90, PXSLIMLAN135STR, PXSLIMLAN135T130, PXSLIMLAN135T45, PXSLIMLAN135T90, PXSLIMLAN150STR, PXSLIMLAN150T130, PXSLIMLAN150T45, PXSLIMLAN150T90, PXSLIMLAN160STR, PXSLIMLAN160T130, PXSLIMLAN160T45, PXSLIMLAN160T90)
- Registration date
- September 05, 2025
- Expiry date
- June 05, 2029
- Source update date
- September 17, 2025
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class IV
Official value: IV
Published parties
- Registrant / registration holder
- Asia Actual Limited
- Manufacturer
- Penumbra, Inc.
Official description
Catheters, Vascular, Microflow
Additional source fields
- AMD nomenclature code
- 10691
- Local responsible person phone
- 28933118
- Published manufacturer address
- One Penumbra Place, Alameda, CA 94502, USA
- Revision number
- a
About this record
This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.