Identity
- Trade Name
- EXCOR® FDA UDI
- Generic Name
- External ventricular circulatory assist system FDA UDI
- Device Name
- Atrial cannula for children EUDAMEDAtrial cannula Ø 12/9 mm; L 32 cm; head 23 mm FDA UDI
- Model / Reference
- C23V-004m EUDAMEDFDA UDI
- Description
- Atrial cannula Ø 12/9 mm; L 32 cm; head 23 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260090041291 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04260090041291 EUDAMED
- PMA Number
- P160035 FDA UDI
- FDA Product Code
- DSQ FDA UDI
- EMDN Code
- C03010499 EXTRACORPOREAL CIRCULATION CANNULAS - OTHER EUDAMED
- GMDN Term
- External ventricular circulatory assist system FDA UDI
Classification
- Device Class
- Class III EUDAMEDFDA 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
Yes
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
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 12 Millimeter FDA UDI
Category: External ventricular circulatory assist system
Excor® by Berlin Heart, Inc. — Class III — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as External ventricular circulatory assist system.
- Art. HLS cannula OD = 17 Fr (5.7 mm) 3/8" connector with LL, insertion length 23 cm — Maquet Cardiopulmonary GmbH · Class III
- Art. HLS cannula OD = 15 Fr (5.0 mm) 3/8" connector with LL, insertion length 15 cm — Maquet Cardiopulmonary GmbH · Class IIa
- Driving tube — Berlin Heart GmbH · Class I
- Novo Surgical — NOVO SURGICAL, INC. · Class I
- Venous HLS Cannula OD= 25Fr (8.3 mm) 3/8" connector without LL, insertion length 55 cm — Maquet Cardiopulmonary GmbH · Class IIa
- Art. HLS cannula OD = 23 Fr (7.7 mm) 3/8" connector with LL, insertion length 23 cm — Maquet Cardiopulmonary GmbH · Class IIa
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Venous HLS Cannula OD= 21Fr (7.0 mm) 3/8" connector without LL, insertion length 38 cm — Maquet Cardiopulmonary GmbH · Class IIa
Cleared under the same submission
P160035 also covers:
- EXCOR® — Berlin Heart, Inc.
- EXCOR® — Berlin Heart, Inc.
- EXCOR® — Berlin Heart, Inc.
- EXCOR® — Berlin Heart, Inc.
- EXCOR® — Berlin Heart, Inc.
- EXCOR® — Berlin Heart, Inc.
- EXCOR® — Berlin Heart, Inc.
- EXCOR® — Berlin Heart, Inc.
- EXCOR® — Berlin Heart, Inc.
- EXCOR® — Berlin Heart, Inc.
- EXCOR® — Berlin Heart, Inc.
- EXCOR® — Berlin Heart, Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class III | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Berlin Heart, Inc.
Sources (2)
- FDA UDI 880587e7-84ba-474c-a42e-12e124550fd4 37 fields · synced Jul 15, 2026
- EUDAMED f240ab18-0bca-4d1f-b82f-acc108a6c5c0 61 fields · synced Jul 15, 2026