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510(k) K130687

2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER by Medical Components, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2013
Date Received
March 13, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

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  • K121848 — SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT (September 21, 2012)
  • K120281 — DIGNITY POWER INJECTABLE TITANIUM PORT (September 17, 2012)

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