Identity
- Trade Name
- INFINITI™ Diagnostic Catheter/SUPER TORQUE™ Diagnostic Catheter/SUPER TORQUE™ Plus Diagnostic Catheter/TEMPO™ AQUA Diagnostic Catheter EUDAMEDTEMPO AQUA FDA UDI
- Generic Name
- Angiographic catheter, single-use FDA UDI
- Device Name
- INFINITI™ Diagnostic Catheter/SUPER TORQUE™ Diagnostic Catheter/SUPER TORQUE™ Plus Diagnostic Catheter/TEMPO™ AQUA Diagnostic Catheter EUDAMEDCATH TEMPO AQUA 5F H1 100CM FDA UDI
- Model / Reference
- 452-535H0 EUDAMED452535H0 FDA UDI
- Description
- CATH TEMPO AQUA 5F H1 100CM FDA UDI
Identifiers
- Catalog Number
- 452535H0 FDA UDI
- Primary DI / UDI-DI
- 20705032009055 EUDAMEDFDA UDI
- Basic UDI-DI
- 07050320000000000000052CL EUDAMED
- 510(k) Number
- K000579 FDA UDI
- FDA Product Code
- DQO FDA UDI
- EMDN Code
- C0104010101,C0104020101 EUDAMED
- GMDN Term
- Angiographic catheter, single-use FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1200 FDA UDI
- Market of Registration
- Netherlands 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
Category: Angiographic catheter, single-use
Tempo Aqua by Cordis Corp. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Angiographic catheter, single-use.
- INFINITI — Cordis US Corp. · Class II
- Performa® — Merit Medical Systems, Inc. · Class II
- Performa® — Merit Medical Systems, Inc. · Class II
- Torcon NB — COOK INCORPORATED · Class II
- Performa® — Merit Medical Systems, Inc. · Class II
- ConcierGE Guiding Excellence™ — Merit Medical Systems, Inc. · Class II
- INFINITI — Cordis US Corp. · Class II
- CXI — COOK INCORPORATED · Class II
Cleared under the same submission
K000579 also covers:
- TEMPO AQUA — Cordis Corp.
- TEMPO AQUA — Cordis Corp.
- TEMPO AQUA — Cordis Corp.
- TEMPO AQUA — Cordis Corp.
- TEMPO AQUA — Cordis Corp.
- TEMPO AQUA — Cordis Corp.
- TEMPO AQUA — Cordis Corp.
- TEMPO AQUA — Cordis Corp.
- TEMPO AQUA — Cordis Corp.
- TEMPO AQUA — Cordis Corp.
- TEMPO AQUA — Cordis Corp.
- TEMPO AQUA — Cordis Corp.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Cordis Corp.
Sources (2)
- FDA UDI ab733cc6-c46a-4714-87ae-aaf9d6967227 36 fields · synced Aug 1, 2026
- EUDAMED c59ee7bd-6eef-4a8e-9c98-7c549c1079d8 61 fields · synced Aug 1, 2026