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510(k) K802260

VASCULAR CATHETER WIREGUIDES by Stanco Medical, Inc. — Product Code DQX

K802260 is an FDA 510(k) premarket notification submitted by Stanco Medical, Inc. for the device "VASCULAR CATHETER WIREGUIDES". The FDA issued a decision of Substantially Equivalent on October 10, 1980. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Stanco Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1980
Date Received
September 16, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Guide, Catheter
Device Class
Class II
Regulation Number
870.1330
Review Panel
CV
Submission Type

Other clearances by Stanco Medical, Inc.

  • K810642 — ATRIAL-VENTRICULAR PACING ELECTRODE KIT (April 8, 1981)
  • K810643 — UNIVERSAL PACING ELECTRODE KIT (April 8, 1981)
  • K802289 — PERICARDIOCENTESIS KIT (November 26, 1980)
  • K802287 — RIGHT ATRIAL LINE KIT (November 20, 1980)
  • K802288 — SWAN GANZ CATHETER PLACEMENT KIT (November 20, 1980)
  • K802259 — TRANSVENOUS PACEMAKER ELECTRODE KIT (October 23, 1980)
  • K802290 — REGIONAL INTRAVENOUS ANESTHESIA KIT (October 17, 1980)
  • K802326 — PRESSURE MONITORING LINES (October 10, 1980)
  • K802327 — SHEATH DILATOR SET (October 10, 1980)
  • K802328 — DISP. TOUGY-BORST TYPE ADAPTOR W/PORT (October 10, 1980)

Other clearances for product code DQX

  • K253667 — Accoat Guide Wire (July 14, 2026)
  • K261640 — Merit MAK Nitinol/Gold-Tungsten Guide Wire (July 13, 2026)
  • K254137 — InQwire Amplatz Guide Wire (May 22, 2026)
  • K260544 — FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40 (March 20, 2026)
  • K253746 — Enroute 0.014'' Transcarotid Guidewire (March 19, 2026)
  • K253262 — EmeryGlide™ (EG18008901) (March 6, 2026)
  • K253847 — Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) (January 31, 2026)
  • K251385 — InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQ (January 21, 2026)
  • K252674 — Solo Pace Fusion System (SOLOFUSE1) (January 9, 2026)
  • K251596 — Lunderquist Extra Stiff Wire Guide (November 9, 2025)

FDA data resources