CARDIOPULMINARY BYPASS CATHETER CANNULA

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

DLP, INC.

The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Cardiopulminary Bypass Catheter Cannula.

Pre-market Notification Details

Device IDK810548
510k NumberK810548
Device Name:CARDIOPULMINARY BYPASS CATHETER CANNULA
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant DLP, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-03-02
Decision Date1981-03-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994374899 K810548 000
20613994495505 K810548 000
20613994495444 K810548 000
20613994495406 K810548 000
20613994495390 K810548 000
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20613994495321 K810548 000
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20613994495529 K810548 000
20613994495543 K810548 000
00643169695948 K810548 000
00673978861579 K810548 000
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00673978861555 K810548 000
20613994736691 K810548 000
20613994736677 K810548 000
20613994495666 K810548 000
20613994495574 K810548 000
20613994495550 K810548 000
00763000192419 K810548 000

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