The following data is part of a premarket notification filed by Axiom Medical, Inc. with the FDA for Catheter Thoracic, Axiom.
| Device ID | K770983 |
| 510k Number | K770983 |
| Device Name: | CATHETER THORACIC, AXIOM |
| Classification | Catheter And Tip, Suction |
| Applicant | AXIOM MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JOL |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-05-31 |
| Decision Date | 1977-07-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M6651000083 | K770983 | 000 |
| M665100020S3 | K770983 | 000 |
| M665100020SC3 | K770983 | 000 |
| M6651000243 | K770983 | 000 |
| M665100024S3 | K770983 | 000 |
| M665100024SC3 | K770983 | 000 |
| M6651000283 | K770983 | 000 |
| M665100028S3 | K770983 | 000 |
| M665100028SC3 | K770983 | 000 |
| M665100028XSP3 | K770983 | 000 |
| M6651000323 | K770983 | 000 |
| M665100032S3 | K770983 | 000 |
| M665100032SC3 | K770983 | 000 |
| M665100032XSP3 | K770983 | 000 |
| M6651000203 | K770983 | 000 |
| M665100016SC3 | K770983 | 000 |
| M665100008S3 | K770983 | 000 |
| M665100008SC3 | K770983 | 000 |
| M6651000103 | K770983 | 000 |
| M665100010S3 | K770983 | 000 |
| M665100010SC3 | K770983 | 000 |
| M6651000123 | K770983 | 000 |
| M665100012S3 | K770983 | 000 |
| M665100012SC3 | K770983 | 000 |
| M6651000143 | K770983 | 000 |
| M665100014S3 | K770983 | 000 |
| M665100014SC3 | K770983 | 000 |
| M6651000163 | K770983 | 000 |
| M665100016S3 | K770983 | 000 |
| M6651000363 | K770983 | 000 |
| M665100036S3 | K770983 | 000 |
| M665111124S3 | K770983 | 000 |
| M665111124SC3 | K770983 | 000 |
| M6651111283 | K770983 | 000 |
| M665111128S3 | K770983 | 000 |
| M665111128SC3 | K770983 | 000 |
| M6651111323 | K770983 | 000 |
| M665111132S3 | K770983 | 000 |
| M665111132SC3 | K770983 | 000 |
| M6651111363 | K770983 | 000 |
| M665111136S3 | K770983 | 000 |
| M665111136SC3 | K770983 | 000 |
| M6651111403 | K770983 | 000 |
| M665111140S3 | K770983 | 000 |
| M6651111243 | K770983 | 000 |
| M665111120SC3 | K770983 | 000 |
| M665100036SC3 | K770983 | 000 |
| M6651000403 | K770983 | 000 |
| M665100040S3 | K770983 | 000 |
| M665100040SC3 | K770983 | 000 |
| M665105203 | K770983 | 000 |
| M665105213 | K770983 | 000 |
| M665105223 | K770983 | 000 |
| M665105233 | K770983 | 000 |
| M6651110163 | K770983 | 000 |
| M665111016S3 | K770983 | 000 |
| M665111016SC3 | K770983 | 000 |
| M6651111203 | K770983 | 000 |
| M665111120S3 | K770983 | 000 |
| M665111140SC3 | K770983 | 000 |