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Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead

FDA 510(k) clearance K190716 · decided 2019-08-08

Clearance details

K-number
K190716
Device name
Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead
Applicant
Medtronic
Decision
Substantially Equivalent
Date received
2019-03-19
Decision date
2019-08-08
Days to decision
142 days
Clearance type
Traditional
Product code
LDF
Device class
2
Regulation number
870.3680
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Santa Ana, CA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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

RecordFirmDate
Sync AV II Temporary Pacing Catheter (K252042)Swift Sync, Inc.2026-07-30
Bioptimal Bipolar Pacing Catheter (K242863)Bioptimal International Pte. , Ltd.2025-06-15
Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) (K251186)C.R. Bard, Inc.2025-05-15
Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH™ Temporary Pacing Electrode Catheter, (K241334)C.R. Bard, Inc.2025-01-31
Rotatable Connector (5944RL) (K241199)Shenzhen Launch Electrical Co., Ltd.2025-01-23
Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500) (K242705)Medtronic, Inc.2025-01-17
TME Temporary Myocardial Electrode (K232261)Osypka AG2024-04-26
Temporary Cardiac Pacing Wire (K173923)ETHICON, Inc.2018-08-02
Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 Unipolar Temporary Myocardial Pacing Lead (K171253)Medtronic2017-05-25
Pacel Flow Directed Pacing Catheter (K161873)St Jude Medical2016-11-22
Tempo Temporary Pacing Lead (K160260)Biotrace Medical, Inc.2016-10-25
Streamline 6495 Bipolar Temporary Myocardial Pacing Lead (K161249)Medtronic2016-08-19

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
HeartWare HVAD System (P100047/S227)Medtronic2025-07-09
HeartWare­™ Ventricular Assist System (HVAD) (P100047/S230)Medtronic2025-06-26
HeartWare™ Ventricular Assist System (HVAD) (P100047/S229)Medtronic2025-06-05
HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S228)Medtronic2025-06-04
HeartWare HVAD System (P100047/S226)Medtronic2025-05-05
HeartWare® HVAD System (P100047/S225)Medtronic2025-04-24
HeartWare HVAD System (P100047/S224)Medtronic2025-04-02
HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S222)Medtronic2025-03-13