BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Catheter

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

Becton, Dickinson And Company

The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Insyte Autoguard Shielded Iv Catheter, Bd Insyte Autoguard Bc Shielded Iv Catheter, Bd Insyte Autoguard Bc Pro Shielded Iv Catheter.

Pre-market Notification Details

• Device ID: K201075
• 510k Number: K201075
• Device Name: BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Catheter
• Classification: Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
• Applicant: Becton, Dickinson And Company 9450 South State Street Sandy, UT 84070
• Contact: Kimberly Geisler
• Correspondent: Kimberly Geisler; Becton, Dickinson And Company 9450 South State Street Sandy, UT 84070
• Product Code: FOZ
• CFR Regulation Number: 880.5200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-04-22
• Decision Date: 2020-12-18

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30382903925545	K201075	000
50382903815574	K201075	000
30382903818236	K201075	000
50382903815123	K201075	000
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50382903925440	K201075	000
50382903826235	K201075	000
50382903826334	K201075	000
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50382903925334	K201075	000
50382903925341	K201075	000
50382903814126	K201075	000
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30382903925125	K201075	000
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50382903925570	K201075	000
50382903926126	K201075	000
50382903926232	K201075	000
50382903926331	K201075	000
30382903926344	K201075	000
50382903926379	K201075	000
50382903926447	K201075	000
30382903926474	K201075	000
50382903819114	K201075	000
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30382903818120	K201075	000
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50382903815376	K201075	000
30382903818441	K201075	000
30382903926542	K201075	000