Shelhigh, Inc.
Union, NJ, US
Shelhigh, Inc. appears in FDA device records in Union, NJ. FDA records list 8 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Shelhigh, Inc. between 1997 and 2003. The busiest year on record is 1998, with 3. The most recent is 2003, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 1 |
| 1998 | 3 |
| 1999 | 1 |
| 2000 | 1 |
| 2003 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K032893 | SHELHIGH NO-REACT BIOCUFF | FTL | Substantially Equivalent | |
| K023940 | SHELHIGH BIORING | KRH | Substantially Equivalent | |
| K982101 | SHELHIGH NO-REACT DURA SHIELD | GXQ | Substantially Equivalent | |
| K991567 | SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH. | FTM | Substantially Equivalent | |
| K982810 | SHELHIGH NO-REACT VASCUPATCH | DXZ | Substantially Equivalent | |
| K981756 | SHELHIGH NO-REACT PNEUMOPLEDGETS | FTL | Substantially Equivalent | |
| K974914 | SHELHIGH NO-REACT PERICARDIAL PATCHES | DXZ | Substantially Equivalent | |
| K964467 | SHELHIGH PERICARDIAL PATCH | DXZ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0678-06 | Shelhigh No-React Pulmonic Valve Conduit. **'Shelhigh No-React, Pulmonic Valve Conduit, NR4000-PA-C'** **'Shelhigh, Inc., 650 Liberty Ave., Union, NJ 07083 USA'** **'Shelhigh Porcine Pulmonic Valve Conduit Prosthesis Model NR-4000 Series with 'No-React' treatment*, INSTRUCTIONS FOR USE'**. | Unapproved Device-Distribution of an unapproved device into interstate commerce. | Terminated | ||
| Z-0588-04 | EnDura No-React Dural Substitute. Product comes in different sizes (2x10, 4x4, 5x6, 6x10, 10x12, and 12 cm diameters), sterile, stored in 2% benzyl alcohol, and distributed by Integra NeuroSciences, Plainsboro, NJ 08536. | The tamper-evident shrink band may fall off causing the user uncertainty whether the product was opened and is still sterile. | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Shelhigh, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain