Atlas FDA

E-CLIP

FDA 510(k) clearance K900982 · decided 1990-04-19

Clearance details

K-number
K900982
Device name
E-CLIP
Applicant
Joel Cohen & Esther R. Cohen
Decision
Substantially Equivalent
Date received
1990-03-02
Decision date
1990-04-19
Days to decision
48 days
Clearance type
Traditional
Product code
LDF
Device class
2
Regulation number
870.3680
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Plantation, FL, 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
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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
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 (K190716)Medtronic2019-08-08
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

Recalls involving this device

No recalls on record reference this clearance.