Peritoneal Introducer & Sheath
FDA 510(k) K771529 · Cordis Corp.
510(k) numberK771529
Submission
- Device name
- Peritoneal Introducer & Sheath
- Applicant
- Cordis Corp.
Mchenry, IL, US - Received
- August 8, 1977
- Decision date
- August 16, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code GYK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K962761 | Reigel Tunneling DeviceGYK · Traditional | Cook, Inc. | 10/11/1996SE |
| K934391 | V/P and L/P Catheter PassersGYK · Traditional | Radionics, Inc. | 11/19/1993SE |
| K930606 | PS Medical Disposable Subcutaneous Cath PasserGYK · Traditional | Pudenz-Schulte Medical Research Corp. | 09/10/1993SE |
| K932273 | Cordis TunnelerGYK · Traditional | Cordis Corp. | 08/23/1993SE |
| K895868 | Heyer-Schulte Disposable Peritoneal Catheter PasseGYK · Traditional | Baxter Healthcare Corp | 10/31/1989SE |
| K883607 | Peel-Away Introducer for Ventricular CatheterGYK · Traditional | Codman & Shurtleff, Inc. | 09/30/1988SE |
| K873771 | Heyer-Schulte(R) One Piece Shunt Vent. Cath. IntroGYK · Traditional | American V. Mueller | 12/18/1987SE |
| K865075 | H-H Subgaleal TrocarGYK · Traditional | Holter-Hausner Intl. | 01/13/1987SE |
| K853370 | H-H Catheter Passers(Tacl DesignGYK · Traditional | Holter-Hausner Intl. | 09/18/1985SE |
| K853368 | H-H Shunt IntroducerGYK · Traditional | Holter-Hausner Intl. | 09/06/1985SE |
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| K202167 | Brite Tip Radianz Guiding SheathDYB · Traditional | 02/26/2021SE |
| K201377 | SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation CatheterLIT · Traditional | 10/09/2020SE |
| K201333 | SABER .035 PTA Dilatation CatheterLIT · Traditional | 09/11/2020SE |
| K181592 | RAIN Sheath TransradialDYB · Traditional | 08/15/2018SE |
| K180081 | RAILWAY Sheathless Access SystemDYB · Traditional | 04/18/2018SE |
| K143412 | ADROIT Guiding CatheterDQY · Special | 01/14/2015SE |
| K133843 | Saber Percutaneous Transluminal Angioplasty Dilatation CatheterLIT · Traditional | 06/27/2014SE |
Questions and answers
When was Peritoneal Introducer & Sheath cleared by the FDA?
Peritoneal Introducer & Sheath (K771529) received a 510(k) decision of Substantially Equivalent on August 16, 1977, 8 days after the submission was received.
What is the product code of K771529?
The FDA product code is GYK – Instrument, Shunt System Implantation, a Class I (low risk) device regulated under 21 CFR 882.4545.