Sterile Cath Care Kit

FDA 510(k) K821500 · Pro-Pak

Substantially Equivalent

510(k) numberK821500

Submission

Device name
Sterile Cath Care Kit
Applicant
Pro-Pak
Mchenry, IL, US
Received
May 19, 1982
Decision date
June 23, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KDD – Kit, Surgical Instrument, Disposable
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Specialty
General, Plastic Surgery

Other 510(k)s with product code KDD

510(k)DeviceApplicantDecision
K072814Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced Laparoscopic…KDD · Traditional Covidien04/16/2008SE
K011514Instruments for One Time Use - DisposableKDD · Traditional Kencap , Ltd.08/13/2001SE
K971317National Medical Healthcare Custom Orthopedic Kits and TraysKDD · Traditional National Healthcare Mfg. Corp.05/08/1997SE
K960456Denver Paracentesis NEEDLE(60-1200) Denver Paracentesis Needle with Drainage…KDD · Traditional Denver Biomaterials, Inc.04/01/1996SE
K936255Custom CV PackKDD · Traditional Associated Medical03/31/1994SN
K932219Suture Set or Laceration Trays (Packs)KDD · Traditional Associated Medical Products Co.07/09/1993SESK
K923176Surgical Instrument Kit, DisposableKDD · Traditional Ulti-Med Intl., Inc.06/17/1993SE
K925905Kit, Surgical Instrument, DisposableKDD · Traditional Kay Medical Concepts06/16/1993SESK
K924958Biopsy/Myelo/Arthro/Amniocent/Basic Skin Prep TrayKDD · Traditional Medical Insights, Inc.06/07/1993SEKD
K925215Sterile Surgical Instrument TraysKDD · Traditional American Healthcare Supply Co., Inc.06/01/1993SEKD

More from American Healthcare Supply Co., Inc.

510(k)DeviceDecision
K821502Sterile Suture Removal KitKDD · Traditional 07/09/1982SE
K821501Sterile Tracheostomy Care KitKDD · Traditional 06/16/1982SE

Questions and answers

When was Sterile Cath Care Kit cleared by the FDA?

Sterile Cath Care Kit (K821500) received a 510(k) decision of Substantially Equivalent on June 23, 1982, 35 days after the submission was received.

What is the product code of K821500?

The FDA product code is KDD – Kit, Surgical Instrument, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.