The following data is part of a premarket notification filed by Intl. Medical Devices Ltd. with the FDA for Thoracic Catheter Stylet.
| Device ID | K913543 |
| 510k Number | K913543 |
| Device Name: | THORACIC CATHETER STYLET |
| Classification | Stylet, Catheter |
| Applicant | INTL. MEDICAL DEVICES LTD. 11845 WEST OLYMPIC BLVD. WESTSIDE TOWERS SUITE 1000 Los Angeles, CA 90064 |
| Contact | Jay Geller |
| Correspondent | Jay Geller INTL. MEDICAL DEVICES LTD. 11845 WEST OLYMPIC BLVD. WESTSIDE TOWERS SUITE 1000 Los Angeles, CA 90064 |
| Product Code | DRB |
| CFR Regulation Number | 870.1380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-09 |
| Decision Date | 1991-10-04 |