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510(k) K875337

HEPARIN COATED LUMINAL PACING CATHETER by Spectramed, Inc. — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 1988
Date Received
December 30, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Diagnostic
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type

Other clearances by Spectramed, Inc.

  • K896122 — AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPED (January 19, 1990)
  • K892941 — CCO SYSTEM MODEL SP1467,SP5567,SP6267 (November 6, 1989)
  • K895323 — MODEL DT-BAL, BALANCE SAVER (October 24, 1989)
  • K894362 — MODEL DT-IUPC2 TRANSDUCER TIPPED DUAL LUMEN IUP (August 15, 1989)
  • K881857 — AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU. (February 1, 1989)
  • K885235 — SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS. (January 25, 1989)
  • K881825 — MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH (September 28, 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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