Atlas FDA

SHILEY MULTIPRO CATHETER

FDA 510(k) clearance K832044 · decided 1983-09-29

Clearance details

K-number
K832044
Device name
SHILEY MULTIPRO CATHETER
Applicant
Shiley, Inc.
Decision
Substantially Equivalent
Date received
1983-06-24
Decision date
1983-09-29
Days to decision
97 days
Clearance type
Traditional
Product code
DXE
Device class
2
Regulation number
870.5150
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Shiley

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

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

RecordFirmDate
Fogarty Thru-Lumen Embolectomy Catheter (K240078)Edwards Lifesciences, LLC2024-08-28
Fogarty Fortis Arterial Embolectomy Catheter (K241330)Edwards Lifesciences2024-07-02
Fogarty Arterial Embolectomy Catheter with Gate Valve (K233820)Edwards Lifesciences2024-05-22
Fogarty Venous Thrombectomy Catheters (K233819)Edwards Lifesciences, LLC2024-05-22
Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters (K233619)Edwards Lifesciences2024-05-20
Merlin Aspiration System (K213771)Mivi Neurovascular, Inc.2022-01-27
Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter (K202049)Applied Medical Resources Corporation2021-09-07
Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe (K193379)Edwards Lifesciences, LLC2020-06-12
Bunegin-Albin Air Aspiration Set (K163031)Cook Incorporated2017-07-27
Needle's Eye Snare Retrieval Set - 54cm (K163353)Cook Incorporated2017-07-11
Export Advance Aspiration Catheter (K152335)Medtronic, Inc.2015-09-18
EMBO PLUS EMBOLECTOMY CATHETER (K100840)Hotspur Technologies2010-07-12

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
BJORK-SHILEY CARDIAC VALVE (P780008/S013)Shiley, Inc.1986-10-31
BJORK-SHILEY CARDIAC VALVE (P780008/S014)Shiley, Inc.1985-04-09
BJORK-SHILEY CARDIAC VALVE (P780008/S015)Shiley, Inc.1984-11-26
BJORK-SHILEY CARDIAC VALVE (P780008/S011)Shiley, Inc.1984-05-15
BJORK-SHILEY CARDIAC VALVE (P780008/S007)Shiley, Inc.1983-05-20
BJORK-SHILEY CARDIAC VALVE (P780008/S005)Shiley, Inc.1982-02-05