Atlas FDA

MODEL 6615 FLOSCAN DOPPLER DIAGNOSTIC CATHETER

FDA 510(k) clearance K862673 · decided 1986-09-11

Clearance details

K-number
K862673
Device name
MODEL 6615 FLOSCAN DOPPLER DIAGNOSTIC CATHETER
Applicant
Medtronic Vascular
Decision
Substantially Equivalent
Date received
1986-07-14
Decision date
1986-09-11
Days to decision
59 days
Clearance type
Traditional
Product code
DQO
Device class
2
Regulation number
870.1200
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
Arterial Pressure Monitoring Set/Tray (K261455)Spectrum Vascular2026-06-26
Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N (K252702)Bioptimal International Pte. , Ltd.2026-05-28
Arterial Pressure Monitoring Set/Tray (K254278)Spectrum Vascular2026-03-25
DualView Catheter (K250751)Terumo Corporation2025-07-17
Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter (K242966)Gentuity, LLC2025-01-31
pNOVUS 21 Microcatheter (K242420)Phenox, Ltd.2024-11-12
Impress Angiographic Catheter (K233268)Merit Medical Systems, Inc.2024-05-22
Zoom 6F Insert Catheters (K233975)Imperative Care, Inc.2024-04-02
Soldier Microcatheter (K232536)Embolx, Inc.2024-02-23
INFINITI™ Ambi Angiographic Catheter (K232573)Cordis US Corp2023-11-21
Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter (K230620)Gentuity, LLC2023-08-08
Drakon™ and Sequre® Microcatheters (K231293)Accurate Medical Therapeutics2023-06-01

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