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510(k) K890707

PHRENIC NERVE PAD & NERVE PAD W/1/4 PERCARDIAL by Dlp, Inc. — Product Code DWS

K890707 is an FDA 510(k) premarket notification submitted by Dlp, Inc. for the device "PHRENIC NERVE PAD & NERVE PAD W/1/4 PERCARDIAL". The FDA issued a decision of Substantially Equivalent on April 10, 1989. The device falls under product code DWS (Instruments, Surgical, Cardiovascular), a Class I device regulated under 21 CFR 870.4500. Dlp, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1989
Date Received
February 10, 1989
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

Other clearances by Dlp, Inc.

  • K973485 — CLEARVIEW BLOWER/MISTER (December 8, 1997)
  • K964445 — OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006) (January 30, 1997)
  • K953945 — RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTR (March 26, 1996)
  • K950754 — MACRO SUCTION TUBE MODEL NO 10061 (April 25, 1995)
  • K934215 — CONTAIN-OR (February 9, 1994)
  • K915268 — CATHETER TWO STAGE VENOUS RETURN (July 27, 1992)
  • K913077 — LANCASTER COOLING JACKET, CAT. CODE #13500/13501 (January 9, 1992)
  • K914608 — BREAST LES LOCAL WIRE ST. 48219/49220/48119/48120 (January 9, 1992)
  • K913098 — APIRATION BIOPSY SYRINGE GUN, CAT. CODE #54501 (November 5, 1991)
  • K912229 — IMA ELECTROCAUTERY ELECTRODE CAT. #60002/60003 (September 25, 1991)

Other clearances for product code DWS

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

FDA data resources