PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETERS

Catheter, Angioplasty, Peripheral, Transluminal

CORDIS CORP.

The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Peripheral Transluminal Angioplasty Catheters.

Pre-market Notification Details

• Device ID: K971010
• 510k Number: K971010
• Device Name: PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETERS
• Classification: Catheter, Angioplasty, Peripheral, Transluminal
• Applicant: CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014
• Contact: Jodi Lynn Greenizen
• Correspondent: Jodi Lynn Greenizen; CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014
• Product Code: LIT
• CFR Regulation Number: 870.1250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-03-20
• Decision Date: 1997-06-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20705032006399	K971010	000
20705032006269	K971010	000
20705032006252	K971010	000
20705032006245	K971010	000
20705032006238	K971010	000
20705032006221	K971010	000
20705032006214	K971010	000
20705032006207	K971010	000
20705032006191	K971010	000
20705032006276	K971010	000
20705032006283	K971010	000
20705032006290	K971010	000
20705032006382	K971010	000
20705032006375	K971010	000
20705032006368	K971010	000
20705032006351	K971010	000
20705032006337	K971010	000
20705032006320	K971010	000
20705032006313	K971010	000
20705032006306	K971010	000
20705032006184	K971010	000
20705032006177	K971010	000
20705032006054	K971010	000
20705032006047	K971010	000
20705032006030	K971010	000
20705032006023	K971010	000
20705032006016	K971010	000
20705032006009	K971010	000
20705032005996	K971010	000
20705032005989	K971010	000
20705032006061	K971010	000
20705032006078	K971010	000
20705032006085	K971010	000
20705032006160	K971010	000
20705032006153	K971010	000
20705032006146	K971010	000
20705032006139	K971010	000
20705032006122	K971010	000
20705032006115	K971010	000
20705032006108	K971010	000
20705032006092	K971010	000
20705032005972	K971010	000
20705032006405	K971010	000
20705032006825	K971010	000
20705032006702	K971010	000
20705032006696	K971010	000
20705032006689	K971010	000
20705032006672	K971010	000
20705032006665	K971010	000
20705032006658	K971010	000
20705032006641	K971010	000
20705032006634	K971010	000
20705032006719	K971010	000
20705032006726	K971010	000
20705032006733	K971010	000
20705032006818	K971010	000
20705032006801	K971010	000
20705032006795	K971010	000
20705032006788	K971010	000
20705032006771	K971010	000
20705032006764	K971010	000
20705032006757	K971010	000
20705032006740	K971010	000
20705032006627	K971010	000
20705032006610	K971010	000
20705032006498	K971010	000
20705032006481	K971010	000
20705032006474	K971010	000
20705032006467	K971010	000
20705032006450	K971010	000
20705032006443	K971010	000
20705032006436	K971010	000
20705032006429	K971010	000
20705032006504	K971010	000
20705032006511	K971010	000
20705032006528	K971010	000
20705032006603	K971010	000
20705032006597	K971010	000
20705032006580	K971010	000
20705032006573	K971010	000
20705032006566	K971010	000
20705032006559	K971010	000
20705032006542	K971010	000
20705032006535	K971010	000
20705032006412	K971010	000