The following data is part of a premarket notification filed by Axiom Medical, Inc. with the FDA for Axiom Thoracic Catheters.
| Device ID | K841593 |
| 510k Number | K841593 |
| Device Name: | AXIOM THORACIC CATHETERS |
| Classification | 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products 510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la |
| Applicant | AXIOM MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-18 |
| Decision Date | 1984-06-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M6655111403 | K841593 | 000 |
| M6655000163 | K841593 | 000 |
| M6655000203 | K841593 | 000 |
| M6655000243 | K841593 | 000 |
| M6655000283 | K841593 | 000 |
| M6655000323 | K841593 | 000 |
| M6655000363 | K841593 | 000 |
| M6655000403 | K841593 | 000 |
| M6655110163 | K841593 | 000 |
| M6655111203 | K841593 | 000 |
| M6655111243 | K841593 | 000 |
| M6655111283 | K841593 | 000 |
| M6655111323 | K841593 | 000 |
| M6655111363 | K841593 | 000 |
| M6655000143 | K841593 | 000 |