The following data is part of a premarket notification filed by Chase Medical, Inc. with the FDA for Chase Cardiovascular Patch Kit.
Device ID | K020233 |
510k Number | K020233 |
Device Name: | CHASE CARDIOVASCULAR PATCH KIT |
Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
Applicant | CHASE MEDICAL, INC. 1710 FIRMAN DR. SUITE 100 Richardson, TX 75081 |
Contact | Dave Hernon |
Correspondent | Dave Hernon CHASE MEDICAL, INC. 1710 FIRMAN DR. SUITE 100 Richardson, TX 75081 |
Product Code | DXZ |
CFR Regulation Number | 870.3470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-01-23 |
Decision Date | 2002-03-14 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00899054002395 | K020233 | 000 |
00899054002098 | K020233 | 000 |
00899054002111 | K020233 | 000 |
00899054002142 | K020233 | 000 |
00899054002166 | K020233 | 000 |
00899054002197 | K020233 | 000 |
00899054002227 | K020233 | 000 |
00899054002234 | K020233 | 000 |
00899054002241 | K020233 | 000 |
00899054002258 | K020233 | 000 |
00899054002326 | K020233 | 000 |
00899054002333 | K020233 | 000 |
00899054002340 | K020233 | 000 |
00899054002357 | K020233 | 000 |
00899054002364 | K020233 | 000 |
00899054002371 | K020233 | 000 |
00899054002388 | K020233 | 000 |
00899054002067 | K020233 | 000 |