The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Peel-away Introducer For Ventricular Catheter.
| Device ID | K883607 |
| 510k Number | K883607 |
| Device Name: | PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER |
| Classification | Instrument, Shunt System Implantation |
| Applicant | Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
| Contact | Thomas J Courage |
| Correspondent | Thomas J Courage Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
| Product Code | GYK |
| CFR Regulation Number | 882.4545 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-23 |
| Decision Date | 1988-09-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20886704042744 | K883607 | 000 |
| 20886704042737 | K883607 | 000 |
| 20886704042720 | K883607 | 000 |
| 00381780521412 | K883607 | 000 |
| 00381780521405 | K883607 | 000 |
| 00381780521399 | K883607 | 000 |