The following data is part of a premarket notification filed by Chestnut Medical Technologies, Inc. with the FDA for Marksmann Catheter.
| Device ID | K091559 |
| 510k Number | K091559 |
| Device Name: | MARKSMANN CATHETER |
| Classification | Catheter, Continuous Flush |
| Applicant | CHESTNUT MEDICAL TECHNOLOGIES, INC. 173 JEFFERSON DRIVE Menlo Park, CA 94025 -1114 |
| Contact | Daniel Cher |
| Correspondent | Daniel Cher CHESTNUT MEDICAL TECHNOLOGIES, INC. 173 JEFFERSON DRIVE Menlo Park, CA 94025 -1114 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-28 |
| Decision Date | 2009-09-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847536026278 | K091559 | 000 |
| 00763000270551 | K091559 | 000 |
| 00763000270544 | K091559 | 000 |
| 00763000270537 | K091559 | 000 |
| 00763000270520 | K091559 | 000 |
| 00763000270384 | K091559 | 000 |
| 00763000270377 | K091559 | 000 |
| 00763000270360 | K091559 | 000 |
| 00763000270353 | K091559 | 000 |
| 00763000270346 | K091559 | 000 |
| 00763000270209 | K091559 | 000 |
| 00763000270193 | K091559 | 000 |
| 00763000270186 | K091559 | 000 |
| 00763000270179 | K091559 | 000 |
| 00763000270568 | K091559 | 000 |
| 00763000270704 | K091559 | 000 |
| 00763000270711 | K091559 | 000 |
| 00847536026261 | K091559 | 000 |
| 00847536026254 | K091559 | 000 |
| 00847536026230 | K091559 | 000 |
| 00847536008335 | K091559 | 000 |
| 00847536008328 | K091559 | 000 |
| 00847536008311 | K091559 | 000 |
| 00847536008304 | K091559 | 000 |
| 00847536003934 | K091559 | 000 |
| 00836462014077 | K091559 | 000 |
| 00836462014060 | K091559 | 000 |
| 00836462014053 | K091559 | 000 |
| 00763000270773 | K091559 | 000 |
| 00763000270766 | K091559 | 000 |
| 00763000270162 | K091559 | 000 |