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510(k) K970690

LOCKING STYLET 2 by Cook Pacemaker Corp. — Product Code DQX

K970690 is an FDA 510(k) premarket notification submitted by Cook Pacemaker Corp. for the device "LOCKING STYLET 2". The FDA issued a decision of Substantially Equivalent on May 20, 1997. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Cook Pacemaker Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1997
Date Received
February 25, 1997
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 Cook Pacemaker Corp.

  • K961992 — NEEDLE'S EYE SNARE (December 27, 1996)
  • K953417 — MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS (September 29, 1995)
  • K915188 — MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEAD (September 11, 1992)
  • K905403 — MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER (October 16, 1991)
  • K863582 — MODEL 725TH HANDHELD TRANSCEIVER (PROGRAMMER) (October 8, 1986)
  • K861559 — SERIES (T) PROGRAMMABLE CARDIAC PULSE GENERATORS (May 9, 1986)
  • K860202 — MODEL 327D, SERIES R UNIPOLAR CARDIAC PULSE GENER. (February 24, 1986)
  • K860466 — MODEL 329D, SERIERS R BIOPOLAR CARDIAC PUL. GEN. (February 24, 1986)
  • K854919 — BIPOLAR CARDIAC PULSE GENERATOR WITH TELEMETRY (December 19, 1985)
  • K854132 — COOK PACEMAKER 332T, SERIES R BIPOLAR CARDIAC PULS (December 3, 1985)

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