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510(k) K881825

MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH by Spectramed, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1988
Date Received
April 29, 1988
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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  • K881857 — AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU. (February 1, 1989)
  • K885235 — SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS. (January 25, 1989)
  • K875337 — HEPARIN COATED LUMINAL PACING CATHETER (May 25, 1988)
  • K880740 — MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE (March 22, 1988)
  • K873168 — SPECTRAMED DISPOSABLE TRANSDUCER (DT-XXO) & ACCESS (January 12, 1988)
  • K871573 — CENTRAL VENOUS MULTI-LUMEN CATHETERS AND KITS (September 16, 1987)

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