Atlas FDA

WIRE DRESSING

FDA 510(k) clearance K874310 · decided 1987-12-23

Clearance details

K-number
K874310
Device name
WIRE DRESSING
Applicant
Slocum and Neal, Inc.
Decision
Substantially Equivalent
Date received
1987-10-20
Decision date
1987-12-23
Days to decision
64 days
Clearance type
Traditional
Product code
LDF
Device class
2
Regulation number
870.3680
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Columbia, MO, 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
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.