Identity
- Trade Name
- Response™ FDA UDI
- Generic Name
- Cardiac mapping catheter, percutaneous, single-use FDA UDI
- Device Name
- Electrophysiology Catheter FDA UDI
- Model / Reference
- 401415 FDA UDI
- Description
- Electrophysiology Catheter FDA UDI
Identifiers
- Catalog Number
- 401415 FDA UDI
- Primary DI / UDI-DI
- 05414734201124 FDA UDI
- FDA Product Code
- DRF FDA UDI
- GMDN Term
- Cardiac mapping catheter, percutaneous, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1220 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Dimensions & Sizes
- Size
- Length — 120 Centimeter FDA UDICatheter Gauge — 6 French FDA UDI
Category: Cardiac mapping catheter, percutaneous, single-use
Response™ by St. Jude Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac mapping catheter, percutaneous, single-use.
- Viking™ — Boston Scientific · Class II
- Inquiry™ AFocus II™ — IRVINE BIOMEDICAL, INC. · Class II
- Woven — Boston Scientific · Class II
- Woven — Boston Scientific · Class II
- AcQRate Dx Steerable Catheter — VascoMed GmbH · Class II
- Map-iT — ACCESS POINT TECHNOLOGIES, INC. · Class II
- Inquiry™ — IRVINE BIOMEDICAL, INC. · Class II
- Woven — Boston Scientific · Class II
Cleared under the same submission
K151622 also covers:
K894500 also covers:
- Response™ — ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
- Response™ — ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
- Response™ — ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
- Response™ — ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
- Response™ — ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
- Response™ — ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
- Response™ — ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
- Response™ — ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
- Response™ — ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
- Response™ — ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
- Response™ — ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
- Response™ — ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- St. Jude Medical, Inc.
Sources (1)
- FDA UDI 7fb1120d-89e3-4b97-8116-eacd19b80fe0 38 fields · synced May 30, 2026