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510(k) K871546

SAFESIDE(TM) LUMED by Luther Medical Products, Inc. — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1987
Date Received
April 20, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

Other clearances by Luther Medical Products, Inc.

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  • K980090 — ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM) (March 24, 1998)
  • K974543 — L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 (February 10, 1998)
  • K940198 — L-CATH CONNECTOR ASSEMBLY (December 15, 1994)
  • K942103 — L-CATH CATHETER SYSTEM - PORT L-CATH (July 26, 1994)
  • K930473 — ONECATH L-CATH CATHETER SYSTEM (April 7, 1994)
  • K925236 — L CATH(R) CATHETER SYSTEM (March 22, 1994)
  • K920755 — L-CATH PEEL AWAY SYSTEM CATHETER (June 7, 1993)
  • K925979 — DUAL LUMEN L-CATH CATHETER SYSTEM (May 27, 1993)
  • K924968 — L-CATH PEEL-AWAY CATHETER SYSTEM (May 21, 1993)

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