Atlas FDA

SCIMED 6 FR., 7 FR., AND 8 FR.,TRIGUIDE GUIDING

FDA 510(k) clearance K932420 · decided 1993-08-17

Clearance details

K-number
K932420
Device name
SCIMED 6 FR., 7 FR., AND 8 FR.,TRIGUIDE GUIDING
Applicant
Scimed Life Systems, Inc.
Decision
Substantially Equivalent
Date received
1993-05-19
Decision date
1993-08-17
Days to decision
90 days
Clearance type
Traditional
Product code
DQO
Device class
2
Regulation number
870.1200
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Maple Grove, MN, 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
Arterial Pressure Monitoring Set/Tray (K261455)Spectrum Vascular2026-06-26
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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
APEX MONORAIL & APEX OTW PTCA DILATATION CATHETER/MAVERICK2 MONORAIL PTCA CATHETER/MAVERICK OTW PTCA CATHETER/MAVERICK (P860019/S264)Scimed Life Systems, Inc.2011-03-31
APEX PTCA & NC QUANTUM APEX PTCA CATHETERS (P860019/S263)Scimed Life Systems, Inc.2010-09-08
MAVERICK2 MONORAIL PTCA DILATATION CATHETER (P860019/S261)Scimed Life Systems, Inc.2010-09-08
PTCA CATHETERS (MAVERICK2/MAVERICK/MAVERICK XL/QUANTUM/MAVERICK/APEX) (P860019/S260)Scimed Life Systems, Inc.2010-09-01
PTCA CATHETERS (P860019/S259)Scimed Life Systems, Inc.2010-08-13
BSC APEX MONORAIL & OTW PTCA DILATATION CATHETERS (P860019/S258)Scimed Life Systems, Inc.2010-07-28
MAVERICK2 MONORAIL & MAVERICK OTW PTCA DILATATION CATHETERS (P860019/S256)Scimed Life Systems, Inc.2010-06-23
APEX PTCA DILATATION CATHETER (P860019/S255)Scimed Life Systems, Inc.2010-05-27