ARTERIAL CANNULA STRAIGHT BEVELED TIP

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 Arterial Cannula Straight Beveled Tip.

Pre-market Notification Details

Device IDK840001
510k NumberK840001
Device Name:ARTERIAL CANNULA STRAIGHT BEVELED TIP
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant DLP, INC. 620 WATSON S.W., P.O. BOX 409 Grand Rapids,  MI  49501
ContactJames Devries
CorrespondentJames Devries
DLP, INC. 620 WATSON S.W., P.O. BOX 409 Grand Rapids,  MI  49501
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-01-03
Decision Date1984-02-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169159723 K840001 000
00643169159068 K840001 000
00643169159075 K840001 000
00643169159082 K840001 000
00643169159099 K840001 000
00643169159105 K840001 000
00643169159112 K840001 000
00643169159297 K840001 000
00643169159303 K840001 000
00643169159051 K840001 000
00643169159044 K840001 000
20643169486045 K840001 000
20643169486052 K840001 000
20643169486069 K840001 000
20643169486076 K840001 000
00673978862156 K840001 000
00673978862163 K840001 000
00643169158900 K840001 000
00643169158917 K840001 000
00643169159310 K840001 000
00643169159457 K840001 000
00643169159648 K840001 000
00643169159655 K840001 000
00643169159662 K840001 000
00643169159679 K840001 000
00643169159686 K840001 000
00643169159693 K840001 000
00643169159709 K840001 000
00643169159716 K840001 000
00643169159631 K840001 000
00643169159624 K840001 000
00643169159464 K840001 000
00643169159471 K840001 000
00643169159495 K840001 000
00643169159501 K840001 000
00643169159563 K840001 000
00643169159594 K840001 000
00643169159600 K840001 000
00643169159617 K840001 000
20643169486038 K840001 000
20643169486021 K840001 000
20643169082766 K840001 000
20643169082780 K840001 000
20643169082797 K840001 000
20643169084319 K840001 000
20643169084388 K840001 000
20643169084395 K840001 000
20643169084401 K840001 000
20643169084425 K840001 000
20613994872375 K840001 000
20613994872368 K840001 000
00763000192792 K840001 000
00763000192808 K840001 000
00763000192815 K840001 000
00763000192822 K840001 000
00763000192839 K840001 000
00763000192846 K840001 000
00763000192853 K840001 000
00763000192860 K840001 000
20643169084432 K840001 000
20643169084449 K840001 000
20643169086931 K840001 000
20643169086948 K840001 000
20643169086955 K840001 000
20643169450930 K840001 000
20643169485901 K840001 000
20643169485918 K840001 000
20643169485925 K840001 000
20643169486014 K840001 000
20643169086559 K840001 000
20643169086542 K840001 000
20643169084456 K840001 000
20643169084524 K840001 000
20643169084548 K840001 000
20643169084555 K840001 000
20643169084579 K840001 000
20643169084593 K840001 000
20643169084609 K840001 000
20643169084807 K840001 000
00763000192761 K840001 000
00643169113206 K840001 000
00643169696358 K840001 000
00643169696365 K840001 000
00643169696372 K840001 000
00643169696389 K840001 000
00643169696396 K840001 000
00643169696402 K840001 000
00643169696419 K840001 000
00643169696426 K840001 000
00643169696341 K840001 000
00643169696334 K840001 000
00643169696167 K840001 000
00643169696174 K840001 000
00643169696211 K840001 000
00643169696228 K840001 000
00643169696235 K840001 000
00643169696242 K840001 000
00643169696259 K840001 000
00643169696327 K840001 000
00643169696433 K840001 000
00643169112735 K840001 000
00643169113121 K840001 000
00643169113138 K840001 000
00643169113145 K840001 000
00643169113152 K840001 000
00643169113169 K840001 000
00643169113176 K840001 000
00643169113183 K840001 000
00643169113190 K840001 000
00643169113114 K840001 000
00643169113107 K840001 000
00643169112742 K840001 000
00643169112759 K840001 000
00643169112766 K840001 000
00643169112773 K840001 000
00643169112803 K840001 000
00643169112810 K840001 000
00643169113084 K840001 000
00643169113091 K840001 000
00643169696150 K840001 000
00643169560949 K840001 000
00643169159952 K840001 000
00643169159969 K840001 000
00643169160071 K840001 000
00643169160088 K840001 000
00643169160095 K840001 000
00643169160101 K840001 000
00643169160149 K840001 000
00643169160163 K840001 000
00643169159945 K840001 000
00643169159938 K840001 000
00643169159747 K840001 000
00643169159754 K840001 000
00643169159761 K840001 000
00643169159778 K840001 000
00643169159785 K840001 000
00643169159907 K840001 000
00643169159914 K840001 000
00643169159921 K840001 000
00643169160170 K840001 000
00643169160187 K840001 000
00643169160293 K840001 000
00643169160309 K840001 000
00643169160323 K840001 000
00643169160330 K840001 000
00643169560901 K840001 000
00643169560918 K840001 000
00643169560925 K840001 000
00643169560932 K840001 000
00643169160286 K840001 000
00643169160279 K840001 000
00643169160194 K840001 000
00643169160200 K840001 000
00643169160217 K840001 000
00643169160224 K840001 000
00643169160231 K840001 000
00643169160248 K840001 000
00643169160255 K840001 000
00643169160262 K840001 000
00643169159730 K840001 000

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