The following data is part of a premarket notification filed by Trireme Medical Inc with the FDA for Chocolate Ptca Bolloon Catheter.
| Device ID | K133633 |
| 510k Number | K133633 |
| Device Name: | CHOCOLATE PTCA BOLLOON CATHETER |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | TRIREME MEDICAL INC 7060 KNOLL CENTER PARKWAY SUITE 300 Pleasanton, CA 94566 |
| Contact | Shiva Ardakani |
| Correspondent | Shiva Ardakani TRIREME MEDICAL INC 7060 KNOLL CENTER PARKWAY SUITE 300 Pleasanton, CA 94566 |
| Product Code | LOX |
| CFR Regulation Number | 870.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-26 |
| Decision Date | 2014-06-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M874CH141403520RX1 | K133633 | 000 |
| M874CH141402015RX1 | K133633 | 000 |
| M874CH141402020RX1 | K133633 | 000 |
| M874CH141402510RX1 | K133633 | 000 |
| M874CH141402515RX1 | K133633 | 000 |
| M874CH141402520RX1 | K133633 | 000 |
| M874CH141403010RX1 | K133633 | 000 |
| M874CH141403015RX1 | K133633 | 000 |
| M874CH141403020RX1 | K133633 | 000 |
| M874CH141403510RX1 | K133633 | 000 |
| M874CH141403515RX1 | K133633 | 000 |
| M874CH141402010RX1 | K133633 | 000 |