SPIRAL-FLEX

Tube, Tracheal (w/wo Connector)

SHERIDAN CATHETER CORP.

The following data is part of a premarket notification filed by Sheridan Catheter Corp. with the FDA for Spiral-flex.

Pre-market Notification Details

Device IDK860105
510k NumberK860105
Device Name:SPIRAL-FLEX
ClassificationTube, Tracheal (w/wo Connector)
Applicant SHERIDAN CATHETER CORP. ROUTE 40 Argyle,  NY  12809
ContactSteen, Ph.d.
CorrespondentSteen, Ph.d.
SHERIDAN CATHETER CORP. ROUTE 40 Argyle,  NY  12809
Product CodeBTR  
CFR Regulation Number868.5730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-01-13
Decision Date1986-03-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
44026704617164 K860105 000
34026704759942 K860105 000
34026704759959 K860105 000
24026704759969 K860105 000
24026704759976 K860105 000
24026704397451 K860105 000
24026704397468 K860105 000
24026704397475 K860105 000
44026704397486 K860105 000
24026704397499 K860105 000
44026704617126 K860105 000
44026704617133 K860105 000
44026704617140 K860105 000
34026704617150 K860105 000
24026704759938 K860105 000

Trademark Results [SPIRAL-FLEX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SPIRAL-FLEX
SPIRAL-FLEX
73768215 1559680 Live/Registered
SHERIDAN CATHETER CORP.
1988-12-02

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.