CORDIS TUNNELER
FDA 510(k) clearance K932273 · decided 1993-08-23
Clearance details
- K-number
- K932273
- Device name
- CORDIS TUNNELER
- Applicant
- Cordis Corp.
- Decision
- Substantially Equivalent
- Date received
- 1993-05-13
- Decision date
- 1993-08-23
- Days to decision
- 102 days
- Clearance type
- Traditional
- Product code
- GYK
- Device class
- 1
- Regulation number
- 882.4545
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| REIGEL TUNNELING DEVICE (K962761) | Cook, Inc. | 1996-10-11 |
| V/P AND L/P CATHETER PASSERS (K934391) | Radionics, Inc. | 1993-11-19 |
| PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER (K930606) | Pudenz-Schulte Medical Research Corp. | 1993-09-10 |
| HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE (K895868) | Baxter Healthcare Corp | 1989-10-31 |
| PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER (K883607) | Codman & Shurtleff, Inc. | 1988-09-30 |
| HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO (K873771) | American V. Mueller | 1987-12-18 |
| H-H SUBGALEAL TROCAR (K865075) | Holter-Hausner Intl. | 1987-01-13 |
| H-H CATHETER PASSERS(TACL DESIGN (K853370) | Holter-Hausner Intl. | 1985-09-18 |
| H-H SHUNT INTRODUCER (K853368) | Holter-Hausner Intl. | 1985-09-06 |
| H-H SHUNT PASSERS (K841553) | Holter-Hausner Intl. | 1984-05-14 |
| H-H SHUNT INTRODUCER (K792639) | Holter-Hausner Intl. | 1979-12-31 |
| PERITONEAL INTRODUCER & SHEATH (K771529) | Cordis Corp. | 1977-08-16 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S086) | Cordis Corp. | 2014-10-10 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S082) | Cordis Corp. | 2012-01-27 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S085) | Cordis Corp. | 2012-01-26 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OVER-THE-WIRE DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTE (P020026/S059) | Cordis Corp. | 2011-05-27 |
| CYPHER SIROLIMUS CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (CYPHER STENT (P020026/S083) | Cordis Corp. | 2011-05-27 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (CYPHER (P020026/S081) | Cordis Corp. | 2011-03-03 |
| CYPHER SIROLIMUS -ELUTING CORONARY STENT (4.0 MM) (P020026/S026) | Cordis Corp. | 2011-02-22 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (P020026/S078) | Cordis Corp. | 2010-09-02 |