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Balanced Nylon Bladder

by Pymah Corp. 510(k)

Active United States

510(k) K930604

Overview

The Balanced Nylon Bladder is a nylon bladder component intended for cardiovascular use. It is a class II medical device that functions as a fluid‑containing element within cardiovascular systems.

The device was cleared by the FDA through a traditional 510(k) submission (K930604) on 30 April 1993, deemed substantially equivalent to a predicate device. It is manufactured by Pymah Corp. in Somerville, New Jersey, and is identified by product code DXQ.

AI-generated from registry data, 21 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK930604 Date30 Apr 1993ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

Full name
Balanced(Tm) Nylon Bladder
510(k) Number
FDA Product Code
DXQ
Device Class
Class II
Regulation
21 CFR Part 870.1120
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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