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510(k) K790124

GRAFT TUNNELER by Narco Scientific — Product Code DWS

K790124 is an FDA 510(k) premarket notification submitted by Narco Scientific for the device "GRAFT TUNNELER". The FDA issued a decision of Substantially Equivalent on Feb 8, 1979. The device falls under product code DWS (Instruments, Surgical, Cardiovascular), a Class I device regulated under 21 CFR 870.4500. Narco Scientific has 29 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 8, 1979
Date Received
Jan 23, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Instruments, Surgical, Cardiovascular
Device Class
Class I
Regulation Number
870.4500
Review Panel
CV
Submission Type
510(k) Exempt

Other clearances by Narco Scientific

  • K830338 — NARCOTRACE 80 (Dec 22, 1983)
  • K831429 — AS 191 ECG TELEMETRY MODULE (Oct 14, 1983)
  • K831428 — AS 1740 INTERFACE MODULE (Oct 14, 1983)
  • K822835 — PZ-800 VOLUME VENTILATOR (Sep 29, 1983)
  • K831430 — AIR SHIELDS AS-100 MONIORING SYS-AS105 (Sep 12, 1983)
  • K831460 — AS 30/TCP MODULE (Jul 12, 1983)
  • K830123 — DISP. YANKAVER SURG. SUCTION INSTRUMENT (Jun 8, 1983)
  • K831028 — TI-1000 TRANSPORT INCUBATOR (May 9, 1983)
  • K823899 — INFANT CARE SYSTEM (Apr 14, 1983)
  • K830680 — AIR-SHIELDS VENTIMETER VENTILATOR-CONTR (Apr 8, 1983)

Other clearances for product code DWS

  • K022238 — MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626 (Oct 9, 2002)
  • K964445 — OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006) (Jan 30, 1997)
  • K962771 — BURKE CONGENITAL THORACOSCOPY INSTRUMENTS (Nov 19, 1996)
  • K955689 — RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY (May 15, 1996)
  • K960139 — G.E. STERILE ANGIOGRAPHIC TRAY (Apr 19, 1996)
  • K960144 — G.E. STERILE CT BIOPSY TRAY (Apr 15, 1996)
  • K960143 — G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY (Apr 9, 1996)
  • K934727 — REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER (Jan 10, 1994)
  • K900379 — HYCULT DIAMOND CORONARY BYPASS KNIFE (Mar 19, 1990)
  • K896307 — INSULATION PAD (Jan 19, 1990)

FDA data resources

Source: FDA 510(k) database entry for K790124. Report a data issue: hello@regdatalab.com.