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510(k) K040786

VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING by Neometrics, Inc. — Product Code DQX

K040786 is an FDA 510(k) premarket notification submitted by Neometrics, Inc. for the device "VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING". The FDA issued a decision of Substantially Equivalent on April 19, 2004. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Neometrics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2004
Date Received
March 29, 2004
Clearance Type
Special
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 Neometrics, Inc.

  • K152560 — Bard Snare Retrieval Kit (October 23, 2015)
  • K150225 — NovaGold High Performance Guidewire (March 16, 2015)
  • K143135 — Spring Coil Guidewire (February 20, 2015)
  • K133076 — NOVAGOLD HIGH PERFORMANCE GUIDEWIRE (February 20, 2014)
  • K123439 — NEO ERCP GUIDEWIRE (January 3, 2013)
  • K101729 — NEOWIRE PTA/PTCA GUIDEWIRE (September 23, 2010)
  • K070150 — VASCUPUNCTURE PICC GUIDEWIRE (February 15, 2007)
  • K043398 — MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE (March 1, 2005)
  • K033321 — SELECTIVA SB GUIDEWIRE (November 5, 2003)
  • K031652 — VASCUPUNCTURE PICC GUIDEWIRE (September 30, 2003)

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