Submission Details
| 510(k) Number | K021593 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 15, 2002 |
| Decision Date | June 13, 2002 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
MODIFICATION TO ENVOY AND VISTA BRITE TIP
Jun 2002
Decision
29d
Days
Class 2
Risk
About This 510(k) Submission
K021593 is an FDA 510(k) clearance for the MODIFICATION TO ENVOY AND VISTA BRITE TIP, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Cordis Corp. (Miami Lakes, US). The FDA issued a Cleared decision on June 13, 2002, 29 days after receiving the submission on May 15, 2002. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.
Device Classification
| Product Code | DQY — Catheter, Percutaneous |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1250 |
Manufacturer
Similar Devices — DQY Catheter, Percutaneous
All 885
K260499 · Abbott Medical
· Mar 2026
K253409 · Medtronic, Inc.
· Dec 2025
K252417 · Abbott Medical
· Dec 2025
K252390 · Medtronic, Ireland
· Oct 2025
K250147 · Centerpoint Systems
· Aug 2025
K251277 · Reflow Medical, Inc.
· Aug 2025
More from Cordis Corp.
View all
K130981
· FGE · Mar 2014
K112797
· LIT · May 2012
K101651
· NTE · Jul 2010
K082143
· PDU · Aug 2008
K062798
· FGE · Feb 2008