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510(k) K821518

MYO/CLIP by Alto Development Corp. — Product Code LDF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1982
Date Received
May 21, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Pacemaker, Temporary
Device Class
Class II
Regulation Number
870.3680
Review Panel
CV
Submission Type

Other clearances by Alto Development Corp.

  • K964621 — A & E MEDICAL ELECTROCAUTERY SUCTION TUBE WITH FINGER TIP ACTIVATOR BUTTON (December 20, 1996)
  • K932513 — LABELING FOR MYO/WIRE II STERNOTOMY SUTURES (January 7, 1994)
  • K931537 — A&E MEDICAL ELECTROSURG ELECTRO W/NON-STICK COAT (September 7, 1993)
  • K930528 — A&E MEDICAL ELECTROSURGICAL CONNECTING CORDS (May 17, 1993)
  • K914193 — A&E MEDICAL CORP DISPOS SUCT COAG W/NON STICK COAT (October 5, 1992)
  • K915300 — A & EM MEDICAL ELECTROSURGICAL PENCIL/ACCESSORIES (February 18, 1992)
  • K884783 — RANEY CLIP (November 30, 1988)
  • K881413 — ELECTRO-CAUTERY SUCTION TUBE (April 21, 1988)
  • K831867 — PRESSURE MONITORING IV BOTTLE CAP (August 12, 1983)

Other clearances for product code LDF

  • K242863 — Bioptimal Bipolar Pacing Catheter (June 15, 2025)
  • K251186 — Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) (May 15, 2025)
  • K241334 — Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Elec (January 31, 2025)
  • K241199 — Rotatable Connector (5944RL) (January 23, 2025)
  • K242705 — Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar T (January 17, 2025)
  • K232261 — TME Temporary Myocardial Electrode (April 26, 2024)
  • K190716 — Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipol (August 8, 2019)
  • K173923 — Temporary Cardiac Pacing Wire (August 2, 2018)
  • K171253 — Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipol (May 25, 2017)
  • K161873 — Pacel Flow Directed Pacing Catheter (November 22, 2016)