Deknatel Thoracic Catheter
by Pfizer Inc. 510(k)
Active
510(k) K852041
Overview
The Deknatel Thoracic Catheter is a medical device designed for use in thoracic applications. It provides temporary wound support to assist in the healing process until the wound can withstand normal stress.
This device is authorized under FDA 510(k) clearance K852041. It is manufactured by Pfizer, Inc. and is categorized under product code JOL.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK852041 | Date17 Jun 1985 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JOL
- FDA applicant
- Pfizer, Inc.
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.6740
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from Pfizer Inc.
Questions
What is the primary purpose of the Deknatel Thoracic Catheter?
This device is designed for use in thoracic applications to provide temporary wound support. It assists in the healing process by supporting the wound site until it is strong enough to withstand normal physiological stress.
What is the regulatory status of this device?
The Deknatel Thoracic Catheter is authorized under FDA 510(k) clearance number K852041. This indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device.
Who is the manufacturer of the Deknatel Thoracic Catheter?
The device is manufactured by Pfizer, Inc., located at 235 E. 42nd St., New York, NY, 10017, United States.