Atlas FDA

GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)

FDA 510(k) clearance K964061 · decided 1997-02-20

Clearance details

K-number
K964061
Device name
GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)
Applicant
W. L. Gore & Associates, Inc.
Decision
Substantially Equivalent
Date received
1996-10-10
Decision date
1997-02-20
Days to decision
133 days
Clearance type
Traditional
Product code
LYK
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Flagstaff, AZ, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

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Vena MicroAngioscope™ System (K251767)Vena Medical Holdings Corp2025-10-01
CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM (K062340)Cardio-Optics, Inc.2006-11-30
CORONARY SINUS ACCESS KIT, MODEL KCS8F-01 (K050808)Cardio-Optics, Inc.2005-07-28
KSEA FIBERSCOPE (K011793)KARL STORZ Endoscopy-America, Inc.2002-04-17
SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273 (K012724)Smith & Nephew, Inc.2001-11-08
KSEA VASCULAR FIBERSCOPES (K001408)KARL STORZ Endoscopy-America, Inc.2000-10-30
4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[ (K952638)Baxter Edwards1995-07-28
APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE (K951721)Applied Medical Resources1995-07-11
APPLIED MEDICAL OPTICAL VALVULOTOME (K945591)Applied Medical Resources1995-02-10
ULTATHIN FLEXIBLE ENDOSCOPE (K941715)Technology Marketing Group1994-10-04
ANGIOSCOPE (K934696)Intramed Laboratories, Inc.1994-01-18

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
GORE® VIABAHN® FORTEGRA Venous Stent (P250017)W. L. Gore & Associates, Inc.2025-12-19
GORE® CARDIOFORM Septal Occluder; GORE® CARDIOFORM ASD Occluder (P050006/S116)W. L. Gore & Associates, Inc.2025-12-19
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S048)W. L. Gore & Associates, Inc.2025-11-24
GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (P040027/S099)W. L. Gore & Associates, Inc.2025-10-27
GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S110)W. L. Gore & Associates, Inc.2025-10-17
GORE® VIABAHN® Endoprosthesis; GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P040037/S171)W. L. Gore & Associates, Inc.2025-10-17
GORE® TAG® Thoracic Branch Endoprosthesis (P210032/S024)W. L. Gore & Associates, Inc.2025-10-17
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S049)W. L. Gore & Associates, Inc.2025-10-17