Sterile Chest Tube

FDA 510(k) K913733 · Vascular Products, Inc.

Substantially Equivalent

510(k) numberK913733

Submission

Device name
Sterile Chest Tube
Applicant
Vascular Products, Inc.
Palm Florida, FL, US
Received
August 20, 1991
Decision date
October 8, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
GBW – Catheter, Peritoneal
Device class
Class I (low risk)
Regulation
21 CFR 878.4200
Specialty
General, Plastic Surgery

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K961194Antimicrobial Mediastinal Silicone DrainGBW · Traditional Sil-Med Corp.08/08/1996SE
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K933510Argyle Turkel Safety Trocar Thoracic CatheterGBW · Traditional Sherwood Medical Co.02/24/1994SE
K926477Bifurcated Suction/Irrigat Tubing Set W/Push ButtoGBW · Traditional Core Dynamics, Inc.11/12/1993SE
K894220Houts Hysterectomy DrainGBW · Traditional Helix Medical, Inc.08/24/1989SE
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K910840Vascular Biopsy ForcepsDWZ · Traditional 07/15/1991SE
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Questions and answers

When was Sterile Chest Tube cleared by the FDA?

Sterile Chest Tube (K913733) received a 510(k) decision of Substantially Equivalent on October 8, 1991, 49 days after the submission was received.

What is the product code of K913733?

The FDA product code is GBW – Catheter, Peritoneal, a Class I (low risk) device regulated under 21 CFR 878.4200.