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subpart-f—cardiovascular-therapeutic-devices/

EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA DILATATION CATHETER, EMERGE OVER-THE-WIRE PTCA DILAT

Page Type: Cleared 510(K)
PDF: FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number: K130391
510(k) Type: Traditional
Applicant: BOSTON SCIENTIFIC CORP.
Country: United States
FDA Decision: Substantially Equivalent
Decision Date: 7/10/2013
Days to Decision: 145 days
Submission Type: Summary

FDA Browser

subpart-f—cardiovascular-therapeutic-devices/

EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA DILATATION CATHETER, EMERGE OVER-THE-WIRE PTCA DILAT

Page Type: Cleared 510(K)
PDF: FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number: K130391
510(k) Type: Traditional
Applicant: BOSTON SCIENTIFIC CORP.
Country: United States
FDA Decision: Substantially Equivalent
Decision Date: 7/10/2013
Days to Decision: 145 days
Submission Type: Summary