Atlas FDA

ANGIOSCOPE

FDA 510(k) clearance K830084 · decided 1983-06-02

Clearance details

K-number
K830084
Device name
ANGIOSCOPE
Applicant
Trimedyne, Inc.
Decision
Substantially Equivalent
Date received
1983-01-11
Decision date
1983-06-02
Days to decision
142 days
Clearance type
Traditional
Product code
LYK
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Walker, MI, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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

RecordFirmDate
Vena MicroAngioscope™ System (K253842)Vena Medical Holdings Corp2026-01-28
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
GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD) (K964061)W. L. Gore & Associates, Inc.1997-02-20
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

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S026)Trimedyne, Inc.1994-03-17
SPECTRAPROBE-PLR CATH. & OPTILASE/CARDIOLASE LASER (P870043/S016)Trimedyne, Inc.1994-03-17
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S027)Trimedyne, Inc.1994-03-01
SPECTRAPROBE-PLR CATH. & OPTILASE/CARDIOLASE LASER (P870043/S015)Trimedyne, Inc.1992-03-20
SPECTRAPROBE-PLR CATH. & OPTILASE/CARDIOLASE LASER (P870043/S014)Trimedyne, Inc.1992-01-29
MODEL 1210 OMNIPULSE(TM) HOLMIUM LASER SYSTEM (P870043/S013)Trimedyne, Inc.1991-08-20
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S025)Trimedyne, Inc.1991-02-25
2.5 HOLIUM/ND:YAG SPECTRAPROBE FLEX CATHETER (P870043/S011)Trimedyne, Inc.1990-11-14