The following data is part of a premarket notification filed by Pediacath Inc. with the FDA for Mongoose Angiographic Catheter.
| Device ID | K113819 |
| 510k Number | K113819 |
| Device Name: | MONGOOSE ANGIOGRAPHIC CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | PEDIACATH INC. 611 WEST 5TH STREET Austin, TX 78701 |
| Contact | Caroline Tontini |
| Correspondent | Caroline Tontini PEDIACATH INC. 611 WEST 5TH STREET Austin, TX 78701 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-27 |
| Decision Date | 2012-07-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14543527226049 | K113819 | 000 |
| 74543527226164 | K113819 | 000 |
| 14543527226179 | K113819 | 000 |
| 14543527226186 | K113819 | 000 |
| 14543527226193 | K113819 | 000 |
| 74543527226201 | K113819 | 000 |
| 74543527226225 | K113819 | 000 |
| 14543527226230 | K113819 | 000 |
| 74543527226249 | K113819 | 000 |
| 14543527226148 | K113819 | 000 |
| 14543527226131 | K113819 | 000 |
| 14543527226056 | K113819 | 000 |
| 14543527226063 | K113819 | 000 |
| 74543527226072 | K113819 | 000 |
| 74543527226089 | K113819 | 000 |
| 74543527226096 | K113819 | 000 |
| 74543527226102 | K113819 | 000 |
| 14543527226117 | K113819 | 000 |
| 14543527226124 | K113819 | 000 |
| 14543527226254 | K113819 | 000 |
| 14543527226261 | K113819 | 000 |
| 74543527226270 | K113819 | 000 |
| 14543527226414 | K113819 | 000 |
| 14543527226421 | K113819 | 000 |
| 14543527226438 | K113819 | 000 |
| 74543527226447 | K113819 | 000 |
| 14543527226469 | K113819 | 000 |
| 14543527229040 | K113819 | 000 |
| 74543527229059 | K113819 | 000 |
| 74543527229066 | K113819 | 000 |
| 74543527226409 | K113819 | 000 |
| 14543527226384 | K113819 | 000 |
| 74543527226287 | K113819 | 000 |
| 14543527226292 | K113819 | 000 |
| 14543527226308 | K113819 | 000 |
| 14543527226315 | K113819 | 000 |
| 74543527226324 | K113819 | 000 |
| 14543527226353 | K113819 | 000 |
| 14543527226360 | K113819 | 000 |
| 14543527226377 | K113819 | 000 |
| 14543527229071 | K113819 | 000 |