Atlas FDA

EN CIRCLR AL ADJUSTABLE LOOP MAPPING CATHETER MODELS, 1045AL1, 1045AL2, 1060AL1, 1060AL2

FDA 510(k) clearance K033050 · decided 2004-03-26

Clearance details

K-number
K033050
Device name
EN CIRCLR AL ADJUSTABLE LOOP MAPPING CATHETER MODELS, 1045AL1, 1045AL2, 1060AL1, 1060AL2
Applicant
Medtronic Vascular
Decision
Substantially Equivalent
Date received
2003-09-29
Decision date
2004-03-26
Days to decision
179 days
Clearance type
Traditional
Product code
DRF
Device class
2
Regulation number
870.1220
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Minneapolis, MN, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Medtronic Vascular

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Vision-MR™ Diagnostic Catheter (K252794)Imricor Medical Systems, Inc.2026-01-08
MAGiC Sweep™ EP Mapping Catheter (K250590)Stereotaxis, Inc.2025-07-23
VIKING™ Fixed Curve Diagnostic Catheter (K250310)Boston Scientific Corporation2025-06-27
EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic Catheter (K240366)Boston Scientific Corporation2024-11-01
Nordica PV Cryo Mapping Catheter (K233900)Synaptic Medical Corporation2024-09-06
Cosine-10TM Diagnostic Catheter (K233397)Medtronic, Inc.2023-12-02
Polaris X™ Unidirectional Steerable Diagnostic Catheter (K233207)Boston Scientific Corporation2023-10-27
BLAZER™ Dx-20 Bidirectional Steerable Diagnostic Catheter (K232651)Boston Scientific Corporation2023-09-29
Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter Cable (K230503)Boston Scientific2023-04-25
EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter (K210313)Shanghai Microport EP Medtech Co., Ltd.2022-12-30
IntellaMap Orion High Resolution Mapping Catheter (K220796)Boston Scientific Corporation2022-06-10
RithmID-SD Steerable Diagnostic Electrophysiology Catheter (K203793)Synaptic Medical Corporation2022-02-14

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Resolute Onyx Zotarolimus-Eluting Coronary Stent System - RX and OTW; Onyx Frontier Zotarolimus-Eluting Coronary Stent S (P160043/S089)Medtronic Vascular2025-12-19
Endurant II/IIs Stent Graft System (P100021/S131)Medtronic Vascular2025-10-23
Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System (P100021/S129)Medtronic Vascular2025-09-15
Resolute Onyx (P160043/S088)Medtronic Vascular2025-06-26
Endurant Stent Graft System (P100021/S130)Medtronic Vascular2025-06-12
Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S073)Medtronic Vascular2025-06-12
Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S072)Medtronic Vascular2025-05-20
Valiant Thoracic Stent Graft with the Captiva Delivery System (P100040/S069)Medtronic Vascular2025-05-08