Atlas FDA

ACS FUNNEL INTRODUCER

FDA 510(k) clearance K875158 · decided 1988-05-31

Clearance details

K-number
K875158
Device name
ACS FUNNEL INTRODUCER
Applicant
Advanced Cardiovascular Systems, Inc.
Decision
Substantially Equivalent
Date received
1987-12-15
Decision date
1988-05-31
Days to decision
168 days
Clearance type
Traditional
Product code
DYB
Device class
2
Regulation number
870.1340
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Temecula, CA, 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
NAMIC Dilator and Sheath (K253526)Medline Industries, LP2026-07-29
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FieldFlex Steerable Sheath (K261492)CenterPoint Systems, LLC2026-06-05
Echo Large Bore Introducer Sheath (K260606)Echo Medical, LLC2026-04-29
Introducer Sheath Set (K254248)Cardiocycle Medical(Suzhou) Co., Ltd.2026-04-23
Edwards eSheath+ introducer set (K254279)Edwards Lifesciences2026-04-17
Aventus Introducer Sheath (K260091)Inquis Medical2026-04-13
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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
CORONARY DILATATION CATHETERS (P810046/S240)Advanced Cardiovascular Systems, Inc.2010-10-15
VOYAGER NC CORONARY DILATATION CATHETER (P810046/S237)Advanced Cardiovascular Systems, Inc.2010-06-01
VOYAGER NC CORONARY DILATATION CATHETER (P810046/S238)Advanced Cardiovascular Systems, Inc.2010-05-13
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETERS VOYAGER/VOYAGER NC (P810046/S236)Advanced Cardiovascular Systems, Inc.2010-04-23
VOYAGER NC CORONARY DILATATION CATHETER (P810046/S234)Advanced Cardiovascular Systems, Inc.2010-03-26
VOYAGER NC CORONARY DILATATION CATHETER (P810046/S232)Advanced Cardiovascular Systems, Inc.2010-02-04
VOYAGER NC CORONARY DILATATION CATHETER (P810046/S230)Advanced Cardiovascular Systems, Inc.2009-07-15
VOYAGER NC CORONARY DILATATION CATHETER (P810046/S231)Advanced Cardiovascular Systems, Inc.2009-05-26