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4MAX DDC - Distal Delivery Catheter, 130 cm
EUDAMEDFDA UDIFDA 510(k)Class III (EU MDR)
Ref 4MAXDDC130Model Distal Delivery Catheter510(k) K122772
Identity
- Trade Name
- 4MAX DDC - Distal Delivery Catheter, 130 cm EUDAMEDPenumbra System FDA UDI
- Generic Name
- Vascular guide-catheter, single-use FDA UDI
- Device Name
- Distal Delivery Catheters EUDAMED4MAX DDC, 130cm FDA UDI
- Model / Reference
- Distal Delivery Catheter EUDAMED4MAXDDC130 EUDAMEDFDA UDI
- Description
- 4MAX DDC, 130cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- D-DDCBY EUDAMED00814548013275 FDA UDI
- Basic UDI-DI
- B-DDCBY EUDAMED
- 510(k) Number
- K122772 FDA UDI
- FDA Product Code
- DQY FDA UDI
- EMDN Code
- C010480 ANGIOGRAPHY AND HEMODYNAMICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Vascular guide-catheter, single-use FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1250 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vascular guidewire introduction sleeve
4MAX DDC - Distal Delivery Catheter, 130 cm by Penumbra, Inc. — Class III — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k)
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K122772 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-DDCBY | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Penumbra, Inc.
- EUDAMED SRN
- US-MF-000008514
- Authorised Representative
- Penumbra Europe GmbH DE-AR-000004997
Sources (3)
- EUDAMED 95ac349c-cb83-4da5-97b0-9d7d8ec23a3a 85 fields · synced Jun 18, 2026
- FDA UDI 485bd894-5324-4353-8559-51549458aaf4 34 fields · synced May 30, 2026
- FDA 510(k) K122772 1 fields · synced May 18, 2026